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Effectiveness of stenting for acute large bowel obstruction
Colorectal cancer (update)
Evidence review C9
NICE Guideline, No. 151
Authors
National Guideline Alliance (UK).London: National Institute for Health and Care Excellence (NICE); 2020 Jan.
ISBN-13: 978-1-4731-3657-1
Copyright © NICE 2020.
Effectiveness of stenting compared with emergency surgery for acute large bowel obstruction
This evidence review supports recommendations 1.3.15 to 1.3.16.
Review question
What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Introduction
Patients presenting with suspected malignant colonic obstruction typically have two treatment options – emergency surgery, which is associated with a number of different complications, including high morbidity and mortality and a high rate of stoma formation; or stenting, which involves placing a hollow, self-expanding, flexible metal tube in the large bowel to keep it open. The use of colonic stents as a bridge to surgery has the potential to convert a bowel obstruction from an emergency condition to an elective situation, yet controversy remains as to whether this treatment option is superior to traditional emergency surgical options. Therefore the aim of this review is to determine the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction.
Summary of the protocol
Please see Table 1 for a summary of the population, intervention, comparison and outcome (PICO) characteristics of this review.
For further details see the review protocol in appendix A.
Methods and process
This evidence review was developed using the methods and process described in Developing NICE guidelines: the manual 2014. Methods specific to this review question are described in the review protocol in appendix A.
Declarations of interest were recorded according to NICE’s 2014 conflicts of interest policy until 31 March 2018. From 1 April 2018, declarations of interest were recorded according to NICE’s 2018 conflicts of interest policy. Those interests declared until April 2018 were reclassified according to NICE’s 2018 conflicts of interest policy (see Register of Interests).
Clinical evidence
Included studies
Thirteen RCTs were included in this review (Alcantara 2011; Cheung 2009; Dutch Stent-In-1 trial [Van Hooft 2008]; Dutch Stent-In-2 trial [Van Hooft 2011]; ESCO trial [Arezzo 2017]; Fiori 2004; Ghazal 2013; Ho 2012; Pirlet 2011; Xinopoulos 2004; Young 2015) and 2 follow up studies Cheung 2009 [Tung 2013]; Dutch Stent-In-2 trial [Sloothaak 2014]).
The included studies are summarised in Table 2.
Four trials (Dutch Stent-In-1 trial [Van Hooft 2008]; Fiori 2004; Xinopoulos 2004; Young 2015) compared stent placement with palliative intent to palliative surgery. Seven trials (Alcantara 2011; Cheung 2009; Dutch Stent-In-2 trial [Van Hooft 2011]; ESCO trial [Arezzo 2017]; Ghazal 2013; Ho 2012; Pirlet 2011) compared stent as a bridge to surgery (SBTS) with emergency surgery.
See the literature search strategy in appendix B and study selection flow chart in appendix C.
Expert evidence
The included studies had low numbers of participants and none was carried out in the UK. Three of these trials were stopped early due to excess treatment related adverse events which led some trialists to question the role of stenting in patients due to receive curative surgery. The CReST trial is a UK phase III randomised trial and is larger than any of the trials published to date. The results from CReST were not published within the timeline of the guideline, however results were available and were presented to the guideline committee by one of the CReST trialists as expert witness evidence.
See the summary of expert evidence in appendix M.
Excluded studies
Studies not included in this review with reasons for their exclusions are provided in appendix K.
Summary of clinical studies included in the evidence review
Summaries of the studies that were included in this review are presented in Table 2.
See the full evidence tables in appendix D and the forest plots in appendix E.
Quality assessment of clinical outcomes included in the evidence review
See the clinical evidence profiles in appendix F.
Economic evidence
Included studies
A systematic review of the economic literature was conducted but no economic studies were identified which were applicable to this review question.
Excluded studies
A global search of economic evidence was undertaken for all review questions in this guideline. See Supplement 2 for further information.
Economic model
No economic modelling was undertaken for this review because the committee agreed that other topics were higher priorities for economic evaluation.
Evidence statements
Clinical evidence statements
Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery
Critical outcomes
Clinically successful bowel decompression, defined by author (stent arm only)
Palliative intent
- Very low quality evidence from 2 RCTs (N=37) showed that clinically successful bowel decompression was achieved in 84% of patients with acute large bowel obstruction undergoing stenting.
Curative intent
- Very low quality evidence from 5 RCTs (N=177) showed that clinically successful bowel decompression was achieved in 69% of patients with acute large bowel obstruction undergoing SBTS.
30-day mortality
Palliative intent
- Very low quality evidence from 3 RCTs (N=95) showed no clinically important difference in 30-day mortality between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Very low quality evidence from 5 RCTs (N=340) showed no clinically important difference in 30-day mortality between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Disease-free survival
Palliative intent
Not applicable.
Curative intent
- Low quality evidence from 2 RCTs (N=106) showed no clinically important difference disease-free survival at 4 to 5 years follow-up between those receiving SBTS and those receiving emergency surgery for patients with acute large bowel obstruction.
- Moderate quality evidence from 1 RCT (N=115) showed no clinically important difference in 3-year progression-free survival between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Important outcomes
Overall survival
Palliative intent
- Low quality evidence from 1 RCT (N=52) showed no clinically important difference in 1-year overall survival between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Moderate quality evidence from 1 RCT (N=48) showed no clinically important difference in 5-year overall survival between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
- Low quality evidence from 1 RCT (N=58) showed no clinically important difference in 4-year overall survival between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
- Moderate quality evidence from 1 RCT (N=115) showed no clinically important difference in 3-year overall survival between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Length of hospital stay
Palliative intent
- Evidence from 2 RCTs (low risk of bias, N=74) showed a clinically important decrease in length of hospital stay (4-5 days less) between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction. However, evidence from 1 RCT (unclear risk of bias, N=21) showed no clinically important decrease in length of hospital stay between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Evidence from 2 RCTs (low risk of bias, N=175) showed a clinically important decrease in length of hospital stay (1-2 days less) between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction. However, evidence from 4 RCTs (high risk of bias, N=196) showed no clinically important decrease in length of hospital stay between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Anastomotic leak
Palliative intent
- Low quality evidence from 1 RCT (N=52) showed no clinically important difference in anastomotic leak between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Very low quality evidence from 7 RCTs (N=447) showed no clinically important difference in anastomotic leak between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Perforation rate (stent arm only)
Palliative intent
No evidence was identified for this outcome in this subgroup.
Curative intent
- Moderate quality evidence from 3 RCTs (N=133) showed that bowel perforation was experienced in 10% of patients with acute large bowel obstruction undergoing SBTS.
Surgical site infection
Palliative intent
- Low quality evidence from 1 RCT (N=52) showed no clinically important difference in surgical site infection between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Very low quality evidence from 6 RCTs (N=387) showed a clinically important decrease in surgical site infection between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Stoma rate
Palliative intent
- Low quality evidence from 1 RCT (N=52) showed a clinically important decrease in stoma rate post-procedure between receiving stenting compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Moderate quality evidence from 4 RCTs (N=312) showed a clinically important decrease in stoma rate post-procedure between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
- Moderate quality evidence from 4 RCTs (N=300) showed a clinically important decrease in stoma rate at last follow-up between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Technically successful stent placement (stent arm only)
Palliative intent
- Very low quality evidence from 3 RCTs (N=52) showed that technical success was achieved in 86% of patients with acute large bowel obstruction undergoing stenting.
Curative intent
- Very low quality evidence from 5 RCTs (N=222) showed that technical success was achieved in 69% of patients with acute large bowel obstruction undergoing SBTS.
Stent failure (stent arm only)
Curative intent
- Low quality evidence from 2 RCTs (N=76) showed that stent failure was experienced in 18% of patients with acute large bowel obstruction undergoing SBTS.
Overall quality of life
Palliative intent
- Low quality evidence from 1 RCT (N=52) showed that while quality of life (measured using EQ-5D) decreased from baseline to 1-year follow-up in both arms, the change was clinically importantly less between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Curative intent
- Low quality evidence from 1 RCT (N=98) showed a clinically important increase in quality of life (measured using EORTC-C30 QL2 subscale) from baseline to 6-months between receiving SBTS compared to emergency surgery for patients with acute large bowel obstruction.
Comparison 2: Stenting followed by palliative care versus best supportive care alone
No evidence was identified to inform this comparison.
Expert evidence statements
Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery
Critical outcomes
Clinically successful bowel decompression, defined by author (stent arm only)
Palliative or curative intent
- Moderate quality expert evidence indicated clinically successful bowel decompression rates of 82% with stenting.
30-day mortality
Palliative intent
There was no expert evidence on this outcome for this subgroup.
Curative intent
- Moderate quality expert evidence indicated no clinically important difference in the 30-day mortality of patients receiving SBTS compared to emergency surgery for acute large bowel obstruction.
Disease-free survival
There was no expert evidence on this outcome.
Important outcomes
Overall survival
Palliative intent
There was no expert evidence on this outcome for this subgroup.
Curative intent
- Moderate quality expert evidence indicated no clinically important difference in the overall survival (at 3 years follow-up) of patients receiving SBTS compared to emergency surgery for acute large bowel obstruction.
Length of hospital stay
Palliative intent
- Moderate quality expert evidence indicated no clinically important difference in the length of hospital stay for patients receiving SBTS compared to emergency surgery for acute large bowel obstruction.
Curative intent
- Moderate quality expert evidence indicated no clinically important difference in the length of hospital stay for patients receiving SBTS compared to emergency surgery for acute large bowel obstruction.
Anastomotic leak
There was no expert evidence on this outcome.
Perforation rate (stent arm only)
Palliative or curative intent
- Moderate quality expert evidence indicated that around 5% of patients receiving SBTS experienced perforation, this rate was relatively low compared to previously published trials.
Surgical site infection
There was no expert evidence on this outcome.
Stoma rate
Palliative intent
There was no expert evidence on this outcome for this subgroup.
Curative intent
- Moderate quality expert evidence indicated a clinically important reduction in stoma rates for patients receiving SBTS compared to emergency surgery for acute large bowel obstruction.
Stent failure (stent arm only)
There was no expert evidence on this outcome.
Overall quality of life
There was no expert evidence on this outcome.
Economic evidence statements
No economic evidence was identified which was applicable to this review question.
The committee’s discussion of the evidence
Interpreting the evidence
The outcomes that matter most
Clinically successful bowel decompression, as defined by the author, was considered a critical outcome as it identifies the clinical success rate of stent placement compared to emergency surgery. 30-day mortality was also a critical outcome as it indicates the technical success rate of stent deployment. Disease-free survival was a critical outcome for decision making because disease progression suggests ineffective management of the cancer and bowel obstruction, potentially requiring further treatment and affecting overall survival, which was considered an important outcome.
Length of hospital stay and treatment-related morbidity (including anastomotic leak, perforation rate, surgical site infection, stoma rate and stent failure) were considered important outcomes because they are indicators of technical success of the stent. Quality of life was an important outcome because of the impact that different treatment options can have on patients’ functioning and the potential long term adverse effects.
The quality of the evidence
Evidence was available for the comparison of stenting followed by planned bowel resection or palliative care versus emergency surgery. Evidence was available for all of the outcomes. No evidence was available for the comparison of stenting followed by palliative care versus best supportive care alone. The quality of the clinical evidence was assessed using GRADE and varied very low to moderate quality.
The quality was downgraded due to lack of blinding in all trials, and inconsistency or imprecision for some outcomes. Although median length of hospital stay was reported by several studies but it was not possible to pool these results using meta-analysis.
An expert witness presented unpublished results of the CReST trial which provided expert evidence for the comparison of stenting followed by planned bowel resection or palliative care versus emergency surgery. This evidence was assessed using GRADE as moderate quality due to imprecision resulting from the sample size of the trial.
Benefits and harms
The recommendations were based on evidence of reduced stoma rates in patients presenting with acute left-sided large bowel obstruction treated with stents compared with those receiving emergency surgery. There was no evidence of a difference in overall or disease-free survival. Potential harms of stenting included perforation, stent failure or failure to achieve technical success and these patients would then require surgery. The committee agreed that stenting was successful for most patients and so the benefits outweighed the harms. This balance was less clear cut for patients to be treated with curative intent who would go on to receive surgery at some point, and for this group the committee recommended both stenting and emergency surgery as options.
The committee also discussed that stenting allows time to fully assess the patient and stabilise any comorbidities before proceeding with further surgery.
The yet to be published results of the CReST trial were consistent with the published evidence and supported the recommendation for stenting as an option for those suitable for potentially curative resection.
Ideally, the decision about whether to offer stenting or emergency surgery should be taken after discussion with relevant specialists (for example colorectal specialist), however, their unavailability should not delay the timely treatment in an emergency situation.
Cost effectiveness and resource use
A systematic review of the economic literature was conducted but no relevant studies were identified which were applicable to this review question.
These recommendations will lead to an increase in stenting as it is not currently established practice for patients with left-sided large bowel obstruction being treated with palliative intent.
It may also require that patients are transferred to other centres to receive stenting. Stenting however allows patients to be assessed and become stable before surgery reducing operative morbidity and preventing expensive surgery in those individuals where it would not be appropriate. Expert evidence from the CReST trial also highlighted there was a lower rate of stoma. All these would reduce downstream costs and improve quality of life.
References
Alcantara 2011
Alcantara M, Serra-Aracil X, Falco J, et al. (2011) Prospective, controlled, randomized study of intraoperative colonic lavage versus stent placement in obstructive left-sided colonic cancer. World Journal of Surgery 35(8): 1904–1910 [PubMed: 21559998]Cheung 2009
Cheung H, Chung C, Tsang W, et al. (2009) Endolaparoscopic approach vs conventional open surgery in the treatment of obstructing left-sided colon cancer: a randomized controlled trial. Archives of Surgery 144(12): 1127–32 [PubMed: 20026830]
Tung K, Cheung H, Ng L, et al. (2013) Endo-laparoscopic approach versus conventional open surgery in the treatment of obstructing left-sided colon cancer: long-term follow-up of a randomized trial. Asian journal of Endoscopic Surgery 6(2): 78–81 [PubMed: 23601995]Dutch Stent-In-1 trial
van Hooft J, Fockens P, Marinelli A, et al. (2008) Early closure of a multicenter randomized clinical trial of endoscopic stenting versus surgery for stage IV left-sided colorectal cancer. Endoscopy 40(3): 184–191 [PubMed: 18322873]Dutch Stent-In-2 trial
Sloothaak D, van den Berg M Dijkgraaf M, et al. (2014) Oncological outcome of malignant colonic obstruction in the Dutch Stent-In 2 trial. British Journal of Surgery 101(13): 1751–1757 2014 [PubMed: 25298250]
van Hooft J, Bemelman W, Oldenburg B, et al. (2011) Colonic stenting versus emergency surgery for acute left-sided malignant colonic obstruction: A multicentre randomised trial. Lancet Oncology 12(4): 344–352 [PubMed: 21398178]ESCO trial
Arezzo A, Balague C, Targarona E, et al. (2017) Colonic stenting as a bridge to surgery versus emergency surgery for malignant colonic obstruction: results of a multicentre randomised controlled trial (ESCO trial). Surgical Endoscopy and Other Interventional Techniques 31(8): 3297–3305 [PubMed: 27924392]Fiori 2004
Fiori E, Lamazza A, De Cesare A, et al. (2004) Palliative management of malignant rectosigmoidal obstruction. Colostomy vs. endoscopic stenting. A randomized prospective trial. Anticancer Research 24(1): 265–268 [PubMed: 15015606]Ghazal 2013
Ghazal A, El-Shazly W, Bessa S, et al. (2013) Colonic Endolumenal Stenting Devices and Elective Surgery Versus Emergency Subtotal/Total Colectomy in the Management of Malignant Obstructed Left Colon Carcinoma. Journal of Gastrointestinal Surgery 17(6): 1123–1129 [PubMed: 23358847]Ho 2012
Ho K, Quah H, Lim J, et al. (2011) Emergency preoperative stenting versus surgery for acute left-sided malignant colonic obstruction: a multicenter randomized controlled trial. Surgical Endoscopy 25(6): 1814–1821 [PubMed: 21170659]Xinopoulos 2004
Xinopoulos D, Dimitroulopoulos D, Theodosopoulos T, et al. (2004) Stenting or stoma creation for patients with inoperable malignant colonic obstructions? Results of a study and cost-effectiveness analysis. Surgical Endoscopy 18(3): 421–426 [PubMed: 14735348]Young 2015
Young C, De-Loyde K, Young J, (2015) Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion. Diseases of the Colon and Rectum 58(9): 838–49 [PubMed: 26252845]
Appendices
Appendix A. Review protocol
Review protocol for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Table 3Review protocol for pharmacological treatments for spasticity
| Field (based on PRISMA-P) | Content |
|---|---|
| Review question | What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction? |
| Type of review question | Intervention |
| Objective of the review | To determine the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction. |
| Eligibility criteria – population/disease/condition/issue/domain |
Adults with acute large bowel obstruction caused by colorectal cancer or suspected colorectal cancer Subgroups:
|
| Eligibility criteria – intervention(s) |
|
| Eligibility criteria – comparator(s) |
|
| Outcomes and prioritisation | Critical outcomes:
|
| Eligibility criteria – study design |
|
| Other inclusion exclusion criteria | Inclusion:
|
| Proposed sensitivity/sub-group analysis, or meta-regression | For observational studies, multivariate analysis should adjust for the following characteristics:
|
| Selection process – duplicate screening/selection/analysis | Sifting, data extraction, appraisal of methodological quality and GRADE assessment will be performed by the systematic reviewer. Resolution of any disputes will be with the senior systematic reviewer and the Topic Advisor. Quality control will be performed by the senior systematic reviewer. |
| Data management (software) |
Pairwise meta-analyses will be performed using Cochrane Review Manager (RevMan5). ‘GRADEpro’ will be used to assess the quality of evidence for each outcome. NGA STAR software will be used for study sifting, data extraction, recording quality assessment using checklists and generating bibliographies/citations. |
| Information sources – databases and dates |
Potential sources to be searched (to be confirmed by Information Scientist): Medline, Medline In-Process, CCTR, CDSR, DARE, HTA, Embase Limits (e.g. date, study design): Apply standard animal/non-English language exclusion Limit to RCTs and systematic reviews in first instance, but download all results Dates: post-2000 |
| Identify if an update | Not an update |
| Author contacts |
https://www Developer: NGA |
| Highlight if amendment to previous protocol | For details please see section 4.5 of Developing NICE guidelines: the manual |
| Search strategy – for one database | For details please see appendix B. |
| Data collection process – forms/duplicate | A standardised evidence table format will be used, and published as appendix D (clinical evidence tables) or H (economic evidence tables). |
| Data items – define all variables to be collected | For details please see evidence tables in appendix D (clinical evidence tables) or H (economic evidence tables). |
| Methods for assessing bias at outcome/study level |
Standard study checklists were used to critically appraise individual studies. For details please see section 6.2 of Developing NICE guidelines: the manual Appraisal of methodological quality: The methodological quality of each study will be assessed using an appropriate checklist:
The risk of bias across all available evidence was evaluated for each outcome using an adaptation of the ‘Grading of Recommendations Assessment, Development and Evaluation (GRADE) toolbox’ developed by the international GRADE working group http://www |
| Criteria for quantitative synthesis (where suitable) | For details please see section 6.4 of Developing NICE guidelines: the manual |
| Methods for analysis – combining studies and exploring (in)consistency |
Synthesis of data: Pairwise meta-analysis of randomised trials will be conducted where appropriate. When meta-analysing continuous data, final and change scores will be pooled if baselines are comparable. If any studies report both, the method used in the majority of studies will be analysed. Minimally important differences: The guideline committee identified statistically significant differences as appropriate indicators for clinical significance for all outcomes except for quality of life for which published MIDs from literature will be used (see outcomes section for more information). |
| Meta-bias assessment – publication bias, selective reporting bias |
For details please see section 6.2 of Developing NICE guidelines: the manual. If sufficient relevant RCT evidence is available, publication bias will be explored using RevMan software to examine funnel plots. |
| Assessment of confidence in cumulative evidence | For details please see sections 6.4 and 9.1 of Developing NICE guidelines: the manual |
| Rationale/context – Current management | For details please see the introduction to the evidence review. |
| Describe contributions of authors and guarantor | A multidisciplinary committee developed the guideline. The committee was convened by The National Guideline Alliance and chaired by Peter Hoskin in line with section 3 of Developing NICE guidelines: the manual. Staff from The National Guideline Alliance undertook systematic literature searches, appraised the evidence, conducted meta-analysis and cost-effectiveness analysis where appropriate, and drafted the guideline in collaboration with the committee. For details please see Supplement 1: methods. |
| Sources of funding/support | The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
| Name of sponsor | The National Guideline Alliance is funded by NICE and hosted by the Royal College of Obstetricians and Gynaecologists |
| Roles of sponsor | NICE funds The National Guideline Alliance to develop guidelines for those working in the NHS, public health, and social care in England |
| PROSPERO registration number | Not registered |
CCTR: Cochrane Central Register of Controlled Trials; CDSR: Cochrane Database of Systematic Reviews; DARE: Database of Abstracts of Reviews of Effects; EQ-5D: EuroQol five dimensions questionnaire; EORTC QLQ-C30: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 Items; EORTC QLQ-CR29: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire colorectal cancer module (29 items); EORTC QLQ-CR38: European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire colorectal cancer module (38 items); FACT-C: Functional Assessment of Cancer Therapy questionnaire (colorectal cancer); FACT-G: Functional Assessment of Cancer Therapy questionnaire (general); GRADE: Grading of Recommendations Assessment, Development and Evaluation; HTA: Health Technology Assessment; MID: minimal important difference; MRI: magnetic resonance imaging; NGA: National Guideline Alliance; NHS: National health service; NICE: National Institute for Health and Care Excellence; PRISMA-P: Preferred Reporting Items for Systematic Reviews and Meta-Analysis Protocols; PROSPERO: International Prospective Register for Systematic Reviews; RCT: randomised controlled trial; RCT: randomised controlled trial; ROBINS-I: Risk of Bias in Non-randomised Studies – of Interventions; ROBIS: risk of bias in systematic reviews; SD: standard deviation
Appendix B. Literature search strategies
Literature search strategies for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Databases: Embase/Medline
Last searched on: 10/01/2019
| # | Search |
|---|---|
| 1 | (exp colorectal cancer/ or exp colon tumor/ or exp rectum tumor/) use emez |
| 2 | exp colorectal neoplasms/ use ppez |
| 3 | ((colorect* or colo rect* or colon or colonic or rectal or rectum) adj3 (adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo?r*)).tw. |
| 4 | or/1-3 |
| 5 | intestine obstruction/ use emez |
| 6 | colon obstruction/ use emez |
| 7 | exp intestinal obstruction/ use ppez |
| 8 | ((bowel or colon or colonic or gastrointestin* or intestine or intestinal) adj4 (obstruct* or block* or occlusion)).tw. |
| 9 | ((adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo?r*) adj4 obstruct*).tw. |
| 10 | or/5-9 |
| 11 | stent/ use emez |
| 12 | stents/ use ppez |
| 13 | stent*.tw. |
| 14 | or/11-13 |
| 15 | 4 and 10 and 14 |
| 16 | remove duplicates from 15 |
| 17 | limit 16 to (yr=“2000 - current” and english language) |
| 18 | Letter/ use ppez |
| 19 | letter.pt. or letter/ use emez |
| 20 | note.pt. |
| 21 | editorial.pt. |
| 22 | Editorial/ use ppez |
| 23 | News/ use ppez |
| 24 | exp Historical Article/ use ppez |
| 25 | Anecdotes as Topic/ use ppez |
| 26 | Comment/ use ppez |
| 27 | Case Report/ use ppez |
| 28 | case report/ or case study/ use emez |
| 29 | (letter or comment*).ti. |
| 30 | or/18-29 |
| 31 | randomized controlled trial/ use ppez |
| 32 | randomized controlled trial/ use emez |
| 33 | random*.ti,ab. |
| 34 | or/31-33 |
| 35 | 30 not 34 |
| 36 | animals/ not humans/ use ppez |
| 37 | animal/ not human/ use emez |
| 38 | nonhuman/ use emez |
| 39 | exp Animals, Laboratory/ use ppez |
| 40 | exp Animal Experimentation/ use ppez |
| 41 | exp Animal Experiment/ use emez |
| 42 | exp Experimental Animal/ use emez |
| 43 | exp Models, Animal/ use ppez |
| 44 | animal model/ use emez |
| 45 | exp Rodentia/ use ppez |
| 46 | exp Rodent/ use emez |
| 47 | (rat or rats or mouse or mice).ti. |
| 48 | or/35-47 |
| 49 | 17 not 48 |
Database: Cochrane Library
Last searched on: 10/01/2019
| # | Search |
|---|---|
| 1 | MeSH descriptor: [Colorectal Neoplasms] explode all trees |
| 2 | ((colorect* or colo rect* or colon or colonic or rectal or rectum) near/3 (adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo*r*)):ti,ab,kw |
| 3 | #1 or #2 |
| 4 | MeSH descriptor: [Intestinal Obstruction] explode all trees |
| 5 | ((bowel or colon or colonic or gastrointestin* or intestine or intestinal) near/3 (obstruct* or block* or occlusion)):ti,ab,kw |
| 6 | ((adenocarcinoma* or cancer* or carcinoma* or malignan* or neoplas* or oncolog* or tumo*r*) near/3 obstruct*):ti,ab,kw |
| 7 | #4 or #5 or #6 |
| 8 | MeSH descriptor: [Stents] this term only |
| 9 | (stent*):ti,ab,kw |
| 10 | #8 or #9 |
| 11 | #3 and #7 and #10 with Cochrane Library publication date Between Jan 2000 and Jan 2019 |
Appendix C. Clinical evidence study selection
Clinical study selection for: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Figure 1Study selection flow chart
Appendix D. Clinical evidence tables
Clinical evidence tables for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Table 4. Clinical evidence tables (PDF, 721K)
Appendix E. Forest plots
Forest plots for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Figure 2Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - clinically successful bowel decompression - Palliative intent, stent arm only
RE: random effect
Figure 3Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - clinically successful bowel decompression – curative intent, stent arm only
RE: random effect
Figure 4Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - 30-day mortality – Palliative intent
CI: confidence interval; M-H: Mantel-Haenszel
Figure 5Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - 30-day mortality – Curative intent
CI: confidence interval; M-H: Mantel-Haenszel
%20%02013%20curative%20intent.&p=BOOKS&id=559925_ch11appef5.jpg "Click on image to zoom")
Figure 6Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – disease free survival (follow up 4 to 5 years) – curative intent
CI: confidence interval; IV: inverse variance
%20%02013%20Curative%20intent.&p=BOOKS&id=559925_ch11appef6.jpg "Click on image to zoom")
Figure 7Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - progression free survival (follow–up 3 years) – Curative intent
CI: confidence interval; IV: inverse variance; SE: standard error
Figure 8Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – overall survival – follow-up 1 to 5 years
CI: confidence interval; IV: inverse variance; SE: standard error
Figure 9Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Anastomotic leak – palliative intent
CI: confidence interval; M-H: Mantel-Haenszel
Figure 10Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Anastomotic leak – curative intent
CI: confidence interval
Figure 11Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Perforation rate - Curative intent, stent arm only
RE: random effect
Figure 12Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - surgical site infection – palliative intent
CI: confidence interval;
Figure 13Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - surgical site infection – curative intent
CI: confidence interval; M-H: Mantel-Haenszel
Figure 14Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - stoma rate
CI: confidence interval; M-H: Mantel-Haenszel
Figure 15Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - technical success – Palliative intent, stent arm only
RE: random effect
Figure 16Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – technical success – Curative intent, stent arm only
RE: random effect
Figure 17Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - stent failure – Curative intent, stent arm only
RE: random effect
Appendix F. GRADE tables
GRADE tables for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Table 5Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Stenting + planned bowel resection or palliative care | Emergency bowel surgery | Relative (95% CI) | Absolute | ||
| Clinically successful bowel decompression, stent arm only - Palliative intent | ||||||||||||
| 2 | randomised trials | no serious risk of bias | serious inconsistency1 | serious2 | serious3 | none |
30/37 (81.1%) | - | Risk 0.84 (0.43 to 0.97) | 840 per 1000 (from 430 to 970) | VERY LOW | CRITICAL |
| Clinically successful bowel decompression, stent arm only - Curative intent | ||||||||||||
| 5 | randomised trials | very serious4,5 | serious inconsistency1 | no serious indirectness | serious3 | none |
123/177 (69.5%) | - |
Risk 0.69 (0.53 to 0.82) | 690 per 1000 (from 530 to 820) | VERY LOW | CRITICAL |
| 30-day mortality - Palliative intent | ||||||||||||
| 3 | randomised trials | serious4 | serious inconsistency1 | serious2 | serious3 | none |
4/48 (8.3%) |
4/47 (8.5%) | RD −0.00 (−0.12 to 0.12) | 0 more per 1000 (from 120 fewer to 120 more) | VERY LOW | CRITICAL |
| 30-day mortality - Curative intent | ||||||||||||
| 5 | randomised trials | very serious4,5 | no serious inconsistency | no serious indirectness | serious3 | none |
9/168 (5.4%) |
10/172 (5.8%) | Peto OR 0.92 (0.36 to 2.34) | 4 fewer per 1000 (from 34 fewer to 63 more) | VERY LOW | CRITICAL |
| Disease free survival, event is disease recurrence or death from any cause (follow-up 4 to 5 years) - Curative intent | ||||||||||||
| 2 | randomised trials | serious6 | no serious inconsistency | no serious indirectness | serious3 | none |
22/50 (44%) |
16/56 (29%) | HR 0.56 (0.29 to 1.06) | At 4 years ES 28.1%b, SBTS 57.2% (27.4% to 78.6%) | LOW | CRITICAL |
| 3-year progression free survival, event is disease recurrence or relapse or death from any cause – Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
17/56 (30%) |
12/59 (20%) | HR 0.95 (0.45 to 2.01) | At 3 years ES 20.3%c, SBTS 22% (4.2% to 48.8%) | MODERATE | CRITICAL |
| 1-year overall survival, event is death from any cause - Palliative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none |
17/26 (65%) |
19/26 (73%) | HR 0.84 (0.44 to 1.6) | At 1 year ES 73.1%d, stenting 76.8% (60.5% to 87.1%) | LOW | IMPORTANT |
| 5-year overall survival, event is death from any cause - Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none | 12/24 | 16/24 | HR 0.51 (0.24 to 1.08) | At 5 years ES 67%a, SBTS 81.5% (64.9% to 90.8%) | MODERATE | IMPORTANT |
| 4-year overall survival, event is death from any cause - Curative intent | ||||||||||||
| 1 | randomised trials | serious6 | no serious inconsistency | no serious indirectness | serious3 | none | 10/26 | 10/32 | HR 0.72 (0.3 to 1.73) | At 4 years ES 31.3%b, SBTS 43.3% (13.4% to 70%) | LOW | IMPORTANT |
| 3-year overall survival, event is death from any cause - Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none | 18/56 | 16/59 | HR 1.00 (0.51 to 1.96) | At 3 years ES 27.1%c, SBTS 27.2% (7.7% to 51.4%) | MODERATE | IMPORTANT |
| Hospital stay - Palliative intent - Fiori 2004 | ||||||||||||
| 1 | randomised trials | serious4 | no serious inconsistency | no serious indirectness | serious3 | none |
N=15 Median= 2.6 |
N=13 Median= 8.1 | p<0.0001 | - | not assessable6 | IMPORTANT |
| Hospital stay - Palliative intent - Dutch Stent-In-1 trial (Van Hooft 2008) | ||||||||||||
| 1 | randomised trials | serious4 | no serious inconsistency | no serious indirectness | serious3 | none |
N=11 Median=12 Range=7-19 |
N=10 Median=11 Range=6.25-17.25 | p=0.46 | - | not assessable6 | IMPORTANT |
| Hospital stay - Palliative intent - Young 2015 | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none |
N=26 Median=7 Range=3-12 |
N=26 Median=11 Range=8-17 | p=0.03 | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - Alcantara 2011 | ||||||||||||
| 1 | randomised trials | very serious4,5 | no serious inconsistency | no serious indirectness | serious3 | none |
N=15 Median=13 |
N=13 Median=10 | p=0.105 | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - Cheung 2009 | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
N=24 Median=13.5 Range=7-29 |
N=24 Median=14 Range=7-55 | p=0.7 | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - ESCO trial (Arezzo 2017) | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
N=56 Median=10 Range=7-13 |
N=59 Median=11 Range=8-15 | - | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - Ghazal 2013 | ||||||||||||
| 1 | randomised trials | serious4 | no serious inconsistency | no serious indirectness | serious3 | none |
N=30 Median=13 |
N=30 Median=8 | p=0.102 | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - Ho 2012 | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
N=20 Median=6 Range=4-28 |
N=19 Median=8 Range=6-39 | p=0.028 | - | not assessable6 | IMPORTANT |
| Hospital stay - Curative intent - Pirlet 2011 | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
N=30 Median=23 Range=9-67 |
N=30 Median=17 (7-126) | p=0.13 | - | not assessable6 | IMPORTANT |
| Anastomotic leak - Palliative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none |
0/26 (0%) |
0/26 (0%) | RD 0.00 (−0.07 to 0.07) | 0 more per 1000 (from 7 fewer to 7 more) | LOW | IMPORTANT |
| Anastomotic leak - Curative intent | ||||||||||||
| 7 | randomised trials | very serious4,5 | no serious inconsistency | no serious indirectness | serious3 | none |
11/221 (5%) |
12/226 (5.3%) | Peto OR 0.92 (0.40 to 2.13) | 4 fewer per 1000 (from 29 fewer to 49 more) | VERY LOW | IMPORTANT |
| Perforation rate, stent arm only - Curative intent | ||||||||||||
| 3 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
13/133 (9.8%) | - | Risk 0.10 (0.06 to 0.17) | 100 per 1000 (from 60 to 170) | MODERATE | IMPORTANT |
| Surgical site infection - Palliative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none |
0/26 (0%) |
1/26 (3.8%) | Peto OR 0.14 (0.00 to 6.82)7 | 33 fewer per 1000 (from 38 fewer to 176 more) | LOW | IMPORTANT |
| Surgical site infection - Curative intent | ||||||||||||
| 6 | randomised trials | very serious4,5 | no serious inconsistency | no serious indirectness | serious3 | none |
14/191 (7.3%) |
35/196 (17.9%) | RR 0.4 (0.22 to 0.71) | 107 fewer per 1000 (from 52 fewer to 139 fewer) | VERY LOW | IMPORTANT |
| Stoma rate - Palliative intent - Postprocedure | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none |
7/26 (26.9%) |
24/26 (92.3%) | RR 0.29 (0.15 to 0.55) | 655 fewer per 1000 (from 415 fewer to 785 fewer) | LOW | IMPORTANT |
| Stoma rate - Curative intent - Postprocedure | ||||||||||||
| 4 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
50/153 (32.7%) |
84/159 (52.8%) | RR 0.62 (0.48 to 0.81) | 201 fewer per 1000 (from 100 fewer to 275 fewer) | MODERATE | IMPORTANT |
| Stoma rate - Curative intent - At last follow up | ||||||||||||
| 4 | randomised trials | no serious risk of bias | no serious inconsistency | no serious indirectness | serious3 | none |
37/147 (25.2%) |
57/153 (37.3%) | RR 0.70 (0.51 to 0.94) | 112 fewer per 1000 (from 22 fewer to 183 fewer) | MODERATE | IMPORTANT |
| Technically successful stent placement, stent arm only - Palliative intent | ||||||||||||
| 3 | randomised trials | serious4 | serious inconsistency1 | serious2 | serious3 | none |
44/52 (84.6%) | - | Risk 0.86 (0.61 to 0.96) | 860 per 1000 (from 610 to 960) | VERY LOW | IMPORTANT |
| Technically successful stent placement, stent arm only - Curative intent | ||||||||||||
| 5 | randomised trials | very serious4,5 | serious inconsistency1 | no serious indirectness | serious3 | none |
174/222 (78.4%) | - | Risk 0.69 (0.66 to 0.72) | 690 per 1000 (from 660 to 720) | VERY LOW | IMPORTANT |
| Stent failure, stent arm only - Curative intent | ||||||||||||
| 2 | randomised trials | no serious risk of bias | serious inconsistency1 | no serious indirectness | serious3 | none |
12/76 (15.8%) | - | Risk 0.18 (0.06 to 0.44) | 180 per 1000 (from 60 to 440) | LOW | IMPORTANT |
| Quality of life - Palliative intent - EQ-5D change score, change from baseline to 1 year (Better indicated by lower values) | ||||||||||||
| 1 | randomised trials | no serious risk of bias | no serious inconsistency | serious2 | serious3 | none | 26 | 26 | - | MD 0.26 higher (0.05 to 0.47 higher) | LOW | IMPORTANT |
| Quality of life - Curative intent - EORTC-C30 QL2 subscale, change from baseline to 6-months (Better indicated by lower values) | ||||||||||||
| 1 | randomised trials | serious9 | no serious inconsistency | no serious indirectness | serious3 | none | 36 | 39 | - | MD 10.1 higher (1.87 to 18.33 higher) | LOW | IMPORTANT |
CI: confidence interval; EQ-5D: EuroQol five dimensions questionnaire: ES: emergency surgery; HR: hazard ratio; MD: mean difference: N: number; OR: odds ratio; RD: risk difference; RR: relative risk; SBTS: stenting as a bridge to surgery
- 1
Quality of evidence downgraded by 1 due to moderate-high heterogeneity (I2 > 40%)
- 2
Quality of evidence downgraded by 1 due to indirectness of the study population - 6/30 (20%) patients had ovarian cancer (Xinopoulos 2004); 12/52 (23%) patients had non-colorectal cancer primaries (Young 2015)
- 3
Quality of evidence downgraded by 1 because of imprecision of the effect estimate (< 300 events for dichotomous outcomes or < 400 patients for continuous outcomes)
- 4
Quality of evidence downgraded by 1 due to failure to report random sequence generation procedure, unclear how attrition was managed, outcomes not pre-specified (Alcantara 2011; Fiori 2004; Ghazal 2013; Xinopoulos 2004)
- 5
Quality of evidence downgraded by 1 because interim safety analyses and termination procedure not determined a priori (Alcantara 2011)
- 6
Quality of evidence downgraded by 1 due to 69% attrition from original sample (Dutch Stent-In-2-Trial [Sloothaak 2014])
- 7
Peto OR used due to zero events in one arm
- 8
Not calculable because of 0 events in both arms
- 9
Quality of evidence downgraded by 1 because lack of blinding could have affected quality of life outcomes (Dutch Stent-In-2 trial [Van Hooft 2011])
- a
The absolute risk at 5 years in the control group taken from Cheung 2009 (Tung 2013)
- b
The absolute risk at 4 years in the control group taken from the Dutch Stent-In-2 trial (Sloothaak 2014)
- c
The absolute risk at 3 years in the control group taken from the ESCO trial (Arezzo 2017)
- d
The absolute risk at 1 year in the control group taken from the Young 2015
Appendix G. Economic evidence study selection
Economic evidence study selection for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
A global search of economic evidence was undertaken for all review questions in this guideline. See Supplement 2 for further information.
Appendix H. Economic evidence tables
Economic evidence tables for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
No economic evidence was identified which was applicable to this review question.
Appendix I. Economic evidence profiles
Economic evidence profiles for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
No economic evidence was identified which was applicable to this review question.
Appendix J. Economic analysis
Economic evidence analysis for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
No economic analysis was conducted for this review question.
Appendix K. Excluded studies
Excluded clinical studies for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
Table 6Excluded studies and reasons for their exclusion
| Study | Reason for exclusion |
|---|---|
| Abelson J. S., Yeo H. L., Mao J., Milsom J. W., Sedrakyan A., Long-term postprocedural outcomes of palliative emergency stenting vs stoma in malignant large-bowel obstruction, JAMA Surgery, 152, 429–435, 2017 [PMC free article: PMC5831448] [PubMed: 28097296] | Cohort study; RCT evidence available |
| Ahn H. J., Kim S. W., Lee S. W., Lim C. H., Kim J. S., Cho Y. K., Park J. M., Lee I. S., Choi M. G., Long-term outcomes of palliation for unresectable colorectal cancer obstruction in patients with good performance status: endoscopic stent versus surgery, Surgical endoscopy and other interventional techniques, 30, 4765–4775, 2016 [PubMed: 26895922] | Cohort study; RCT evidence available |
| Allaix M. E., Arezzo A., Balague C., Targarona E. M., Morino M., Esco trial: colonic stent versus emergency surgery in malignant colonic occlusion, an interim report, European surgical research., 45, 210â□□211, 2010 | Conference abstract |
| Allievi N., Ceresoli M., Fugazzola P., Montori G., Coccolini F., Ansaloni L., Endoscopic Stenting as Bridge to Surgery versus Emergency Resection for Left-Sided Malignant Colorectal Obstruction: An Updated Meta-Analysis, International journal of surgical oncology, 2017, 2863272, 2017 [PMC free article: PMC5516723] [PubMed: 28761765] | A systematic review, included studies checked for relevance. All studies individually included in review |
| Amelung F. J., Burghgraef T. A., Tanis P. J., van Hooft J. E., ter Borg F., Siersema P. D., Bemelman W. A., Consten E. C. J., Critical appraisal of oncological safety of stent as bridge to surgery in left-sided obstructing colon cancer; a systematic review and meta-analysis, Critical Reviews in Oncology/Hematology, 131, 66–75, 2018 [PubMed: 30293707] | A systematic review, included studies checked for relevance. |
| Amelung F. J., de Beaufort H. W. L., Siersema P. D., Verheijen P. M., Consten E. C. J., Emergency resection versus bridge to surgery with stenting in patients with acute right-sided colonic obstruction: a systematic review focusing on mortality and morbidity rates, International journal of colorectal disease, 30, 1147–1155, 2015 [PubMed: 25935448] | A systematic review, included studies checked for relevance. |
| Amelung F. J., Draaisma W. A., Consten E. C. J., Siersema P. D., ter Borg F., Self-expandable metal stent placement versus emergency resection for malignant proximal colon obstructions, Surgical Endoscopy and Other Interventional Techniques, 31, 4532–4541, 2017 [PubMed: 28409374] | Prospective cohort study; RCT evidence available |
| Amelung F. J., Draaisma W. A., Consten E. C. J., Siersema P. D., Ter Borg F. J., A case-matched comparative study of self-expandable metal stent placement and emergency resection in the management of proximal colonic obstructions, Surgical Endoscopy and Other Interventional Techniques, 31 (2 Supplement 1), S362, 2017 | Conference abstract |
| Amelung F. J., ter Borg F., Consten E. C. J., Siersema P. D., Draaisma W. A., Deviating colostomy construction versus stent placement as bridge to surgery for malignant left-sided colonic obstruction, Surgical endoscopy and other interventional techniques, 30, 5345â□□5355, 2016 [PubMed: 27071927] | Prospective cohort study; RCT evidence available |
| Angenete E., Asplund D., Bergstrom M., Park P. O., Stenting for colorectal cancer obstruction compared to surgery-a study of consecutive patients in a single institution, International journal of colorectal disease, 27, 665â□□670, 2012 [PubMed: 22124678] | Prospective cohort study; RCT evidence available |
| Arezzo A., Passera R., Lo Secco G., Verra M., Bonino M. A., Targarona E., Morino M., Stent as bridge to surgery for left-sided malignant colonic obstruction reduces adverse events and stoma rate compared with emergency surgery: results of a systematic review and meta-analysis of randomized controlled trials, Gastrointestinal endoscopy, 86, 416–426, 2017 [PubMed: 28392363] | A systematic review, included studies checked for relevance. |
| Atukorale Y. N., Church J. L., Hoggan B. L., Lambert R. S., Gurgacz S. L., Goodall S., Maddern G. J., Self-Expanding Metallic Stents for the Management of Emergency Malignant Large Bowel Obstruction: a Systematic Review, Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract, 20, 455–462, 2016 [PubMed: 26501483] | A systematic review, included studies checked for relevance. |
| Baik S. H., Kim N. K., Cho H. W., Lee K. Y., Sohn S. K., Cho C. H., Kim T. I., Kim W. H., Clinical outcomes of metallic stent insertion for obstructive colorectal cancer, Hepato-Gastroenterology, 53, 183–187, 2006 [PubMed: 16608020] | Prospective cohort study; RCT evidence available |
| Bergstrom M., Stolt R., Cikota P., Ahlen R., Park P. O., Inflammatory response to acute treatment of colonic obstruction due to colorectal malignancy, comparing colonic stenting and surgery, Surgical endoscopy and other interventional techniques, 32 (1 Supplement 1), S207, 2018 | Conference abstract; retrospective cohort study |
| Breitenstein S., Rickenbacher A., Berdajs D., Puhan M., Clavien P. A., Demartines N., Systematic evaluation of surgical strategies for acute malignant left-sided colonic obstruction, British journal of surgery, 94, 1451–1460, 2007 [PubMed: 17968980] | A systematic review, included studies checked for relevance. |
| Carne P. W. G., Frye J. N. R., Robertson G. M., Frizelle F. A., Stents or open operation for palliation of colorectal cancer: A retrospective, cohort study of perioperative outcome and long-term survival, Diseases of the colon and rectum, 47, 1455–1461, 2004 [PubMed: 15486741] | Retrospective cohort study; RCT evidence available |
| Cennamo V., Luigiano C., Coccolini F., Fabbri C., Bassi M., De Caro G., Ceroni L., Maimone A., Ravelli P., Ansaloni L., Meta-analysis of randomized trials comparing endoscopic stenting and surgical decompression for colorectal cancer obstruction, International journal of colorectal disease, 28, 855–863, 2013 [PubMed: 23151813] | A systematic review, included studies checked for relevance. |
| Cennamo V., Luigiano C., Manes G., Zagari R. M., Ansaloni L., Fabbri C., Ceroni L., Catena F., Pinna A. D., Fuccio L., et al.,, Colorectal stenting as a bridge to surgery reduces morbidity and mortality in left-sided malignant obstruction: a predictive risk score-based comparative study, Digestive and liver disease, 44, 508â□□514, 2012 [PubMed: 22265809] | Prospective cohort study; RCT evidence available |
| Ceresoli M., Allievi N., Coccolini F., Montori G., Fugazzola P., Pisano M., Sartelli M., Catena F., Ansaloni L., Long-term oncologic outcomes of stent as a bridge to surgery versus emergency surgery in malignant left side colonic obstructions: A meta-analysis, Journal of Gastrointestinal Oncology, 8, 867–876, 2017 [PMC free article: PMC5674262] [PubMed: 29184691] | A systematic review, included studies checked for relevance. |
| Choi J. M., Lee C., Han Y. M., Lee M., Choi Y. H., Jang D. K., Im J. P., Kim S. G., Kim J. S., Jung H. C., Long-term oncologic outcomes of endoscopic stenting as a bridge to surgery for malignant colonic obstruction: Comparison with emergency surgery, Surgical Endoscopy and Other Interventional Techniques, 28, 2649–2655, 2014 [PubMed: 24789126] | Prospective cohort study; RCT evidence available |
| Cirocchi R., Farinella E., Trastulli S., Desiderio J., Listorti C., Boselli C., Parisi A., Noya G., Sagar J., Safety and efficacy of endoscopic colonic stenting as a bridge to surgery in the management of intestinal obstruction due to left colon and rectal cancer: a systematic review and meta-analysis, Surgical OncologySurg Oncol, 22, 14–21, 2013 [PubMed: 23183301] | A systematic review, included studies checked for relevance. |
| Consolo P., Giacobbe G., Cintolo M., Tortora A., Fama F., Gioffre-Florio M., Pallio S., Colonic acute malignant obstructions: Effectiveness of self-expanding metallic stent as bridge to surgery, Turkish Journal of Gastroenterology, 28, 40–45, 2017 [PubMed: 28007677] | Retrospective cohort study; RCT evidence available |
| Crespi-Mir A., Romero-Marcos J. M., de la Llave-Serralvo A., Dolz-Abadia C., Cifuentes-Rodenas J. A., Impact on surgical and oncological results of the use of colonic stents as a bridge to surgery for potentially curable occlusive colorectal neoplasms, Cirugia espanola, 96, 419–428, 2018 [PubMed: 29669684] | Retrospective cohort study; RCT evidence available |
| Cui J., Zhang J. L., Wang S., Sun Z. Q., Jiang X. L., A preliminary study of stenting followed by laparoscopic surgery for obstructing left-sided colon cancer, Zhonghua wei chang wai ke za zhi [Chinese journal of gastrointestinal surgery], 14, 40â□□43, 2011 [PubMed: 21271379] | Article in Chinese |
| Currie A., Christmas C., Aldean H., Mobasheri M., Bloom I. T. M., Systematic review of self-expanding stents in the management of benign colorectal obstruction, Colorectal Disease, 16, 239–245, 2014 [PubMed: 24033989] | A systematic review, included studies checked for relevance. |
| Dastur J. K., Forshaw M. J., Modarai B., Solkar M. M., Raymond T., Parker M. C., Comparison of short-and long-term outcomes following either insertion of self-expanding metallic stents or emergency surgery in malignant large bowel obstruction, Techniques in Coloproctology, 12, 51–55, 2008 [PubMed: 18512013] | Retrospective cohort study; RCT evidence available |
| De Ceglie A., Filiberti R., Baron T. H., Ceppi M., Conio M., A meta-analysis of endoscopic stenting as bridge to surgery versus emergency surgery for left-sided colorectal cancer obstruction, Critical Reviews in Oncology/Hematology, 88, 387–403, 2013 [PubMed: 23845505] | A systematic review, included studies checked for relevance. |
| Faragher I. G., Chaitowitz I. M., Stupart D. A., Long-term results of palliative stenting or surgery for incurable obstructing colon cancer, Colorectal disease, 10, 668–672, 2008 [PubMed: 18266885] | Retrospective cohort study; RCT evidence available |
| Finlayson A., Hulme-Moir M., Palliative colonic stenting: a safe alternative to surgery in stage IV colorectal cancer, ANZ Journal of Surgery, 86, 773–777, 2016 [PubMed: 25143253] | Retrospective cohort study; RCT evidence available |
| Fiori E., Lamazza A., Schillaci A., Femia S., Demasi E., Decesare A., Sterpetti A. V., Palliative management for patients with subacute obstruction and stage IV unresectable rectosigmoid cancer: Colostomy versus endoscopic stenting: Final results of a prospective randomized trial, American Journal of Surgery, 204, 321–326, 2012 [PubMed: 22575396] | Follow up study of Fiori 2004 (included in review), outcomes not relevant |
| Flor-Lorente B., Báguena, G., Frasson M., García-Granero A., Cervantes A., Sanchiz V., Peña, A., Espí, A., Esclapez P., García-Granero E., Self-expanding metallic stent as a bridge to surgery in the treatment of left colon cancer obstruction: cost-benefit analysis and oncologic results, Cirugia espanola, 95, 143â□□151, 2017 [PubMed: 28336185] | Prospective cohort study; RCT evidence available |
| Foo C. C., Poon S. H. T., Chiu R. H. Y., Lam W. Y., Cheung L. C., Law W. L., Is bridge to surgery stenting a safe alternative to emergency surgery in malignant colonic obstruction: a meta-analysis of randomized control trials, Surgical Endoscopy., 2018 [PubMed: 30341649] | A systematic review, included studies checked for relevance. |
| Formisano V., Di Muria A., Connola G., Cione G., Falco L., De Angelis C. P., Angrisani L., Our experience in the management of obstructing colorectal cancer, Annali italiani di chirurgia, 85, 563–568, 2014 [PubMed: 25711439] | Article in Italian |
| Frago R., Ramirez E., Millan M., Kreisler E., Del Valle E., Biondo S., Current management of acute malignant large bowel obstruction: A systematic review, American journal of surgery, 207, 127–138, 2014 [PubMed: 24124659] | A systematic review, included studies checked for relevance. |
| Gianotti L., Tamini N., Nespoli L., Rota M., Bolzonaro E., Frego R., Redaelli A., Antolini L., Ardito A., Nespoli A., Dinelli M., A prospective evaluation of short-term and long-term results from colonic stenting for palliation or as a bridge to elective operation versus immediate surgery for large-bowel obstruction, Surgical endoscopy, 27, 832–42, 2013 [PubMed: 23052501] | Prospective cohort study; RCT evidence available |
| Gibor U., Perry Z. H., Tirosh D., Netz U., Rosental A., Fich A., Man S., Ariad S., Kirshtein B., Comparison of the long-term oncological outcomes of stent as a bridge to surgery and surgery alone in malignant colonic obstruction, Israel Medical Association Journal, 19, 736–740, 2017 [PubMed: 29235734] | Retrospective cohort study; RCT evidence available |
| Gorissen K. J., Tuynman J. B., Fryer E., Wang L., Uberoi R., Jones O. M., Cunningham C., Lindsey I., Local recurrence after stenting for obstructing left-sided colonic cancer, British journal of surgery, 100, 1805–1809, 2013 [PubMed: 24227368] | Prospective cohort study; RCT evidence available |
| Guo M. G., Feng Y., Liu J. Z., Zheng Q., Di J. Z., Wang Y., Fan Y. B., Huang X. Y., Factors associated with mortality risk for malignant colonic obstruction in elderly patients, BMC Gastroenterology, 14 (1) (no pagination), 2014 [PMC free article: PMC3998070] [PubMed: 24735084] | Retrospective cohort study; RCT evidence available |
| Guo M. G., Feng Y., Zheng Q., Di J. Z., Wang Y., Fan Y. B., Huang X. Y., Comparison of self-expanding metal stents and urgent surgery for left-sided malignant colonic obstruction in elderly patients, Digestive Diseases and Sciences, 56, 2706–2710, 2011 [PubMed: 21442324] | Retrospective cohort study; RCT evidence available |
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| Hanabata N., Sasaki Y., Kanazawa K., Igarashi S., Hasui K., Shimaya K., Numao H., Munakata M., Fukuda S., A comparative study on efficacy of chemotherapy after endoscopic colonic stenting vs. That after colonic surgery in the management of obstructive colorectal cancer, United European Gastroenterology Journal, 5 (5 Supplement 1), A557, 2017 | Conference abstract |
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| Kang S. I., Oh H. K., Yoo J. S., Ahn S., Kim M. H., Son I. T., Kim D. W., Kang S. B., Park Y. S., Yoon C. J., Shin R., Heo S. C., Lee I. T., Youk E. G., Kim M. J., Chang T. Y., Park S. C., Sohn D. K., Oh J. H., Park J. W., Ryoo S. B., Jeong S. Y., Park K. J., Oncologic outcomes of preoperative stent insertion first versus immediate surgery for obstructing left-sided colorectal cancer, Surgical Oncology, 27, 216–224, 2018 [PubMed: 29937174] | Retrospective cohort study; RCT evidence available |
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| Martinez-Santos C., Lobato R. F., Fradejas J. M., Pinto I., Ortega-Deballon P., Moreno-Azcoita M., Self-expandable stent before elective surgery vs. emergency surgery for the treatment of malignant colorectal obstructions: Comparison of primary anastomosis and morbidity rates, Diseases of the colon and rectum, 45, 401–406, 2002 [PubMed: 12068202] | Prospective cohort study; RCT evidence available |
| Morita S., Yamamoto K., Ogawa A., Naito A., Mizuno H., Yoshioka S., Matsumura T., Ohta K., Suzuki R., Matsuda C., Hata T., Nishimura J., Mizushima T., Doki Y., Mori M., Miyake M., Miyoshi N., Tamagawa H., Ohta H., Nushijima Y., Danno K., Takemoto H., Fumimoto Y., Ohashi I., Benefits of using a self-expandable metallic stent as a bridge to surgery for right- and left-sided obstructive colorectal cancers, Surgery Today, 49, 32–37, 2019 [PubMed: 30105529] | Retrospective cohort study; RCT evidence available |
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| Ng K. C., Law W. L., Lee Y. M., Choi H. K., Seto C. L., Ho J. W. C., Self-Expanding Metallic Stent as a Bridge to Surgery Versus Emergency Resection for Obstructing Left-Sided Colorectal Cancer: A Case-Matched Study, Journal of gastrointestinal surgery, 10, 798–803, 2006 [PubMed: 16769535] | Prospective cohort study; RCT evidence available |
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| Park J., Lee H. J., Park S. J., Hur H., Min B. S., Cheon J. H., Kim T. I., Kim N. K., Kim W. H., Long-term outcomes after stenting as a bridge to surgery in patients with obstructing left-sided colorectal cancer, International journal of colorectal disease, 33, 799–807, 2018 [PubMed: 29532209] | Retrospective cohort study; RCT evidence available |
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| Ptok H., Marusch F., Steinert R., Meyer L., Lippert H., Gastinger I., Incurable stenosing colorectal carcinoma: Endoscopic stent implantation or palliative surgery?, World journal of surgery, 30, 1481–1487, 2006 [PubMed: 16850152] | Prospective cohort study; RCT evidence available |
| Quereshy F. A., Poon J. T. C., Law W. L., Long-term outcome of stenting as a bridge to surgery for acute left-sided malignant colonic obstruction, Colorectal disease, 16, 788–793, 2014 [PubMed: 24836397] | Retrospective cohort study; RCT evidence available |
| Rees J., Tanner J., Patel P., Trudgill N., The outcomes of self-expanding metal stents as a bridge to curative resection in patients with colorectal cancer presenting with bowel obstruction, United European Gastroenterology Journal, 4 (5 Supplement 1), A664, 2016 | Conference abstract |
| Ribeiro I. B., Bernardo W. M., Martins B. D. C., de Moura D. T. H., Baba E. R., Josino I. R., Miyahima N. T., Coronel Cordero M. A., Visconti T. A. C., Ide E., Sakai P., de Moura E. G. H., Colonic stent versus emergency surgery as treatment of malignant colonic obstruction in the palliative setting: a systematic review and meta-analysis, Endoscopy International Open, 6, E558–E567, 2018 [PMC free article: PMC5943694] [PubMed: 29756013] | A systematic review, included studies checked for relevance. |
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| Takahashi H., Okabayashi K., Tsuruta M., Hasegawa H., Yahagi M., Kitagawa Y., Self-Expanding Metallic Stents Versus Surgical Intervention as Palliative Therapy for Obstructive Colorectal Cancer: A Meta-analysis, World journal of surgery, 39, 2037–2044, 2015 [PubMed: 25894403] | A systematic review, included studies checked for relevance |
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RCT: randomised controlled trial
Appendix L. Research recommendations
Research recommendations for review question: What is the effectiveness of stenting compared with emergency surgery for suspected colorectal cancer causing acute large bowel obstruction?
No research recommendations were made for this review question. 6
Appendix M. Expert evidence
Table 8Gaps addressed and recommendations supported by expert evidence
| Expert evidence | Gaps addressed | Recommendations supported |
|---|---|---|
|
|
|
CReST: ColoRectal endoscopic Stenting Trial
Table 9Quality assessment of expert evidence – outcomes in the public domain4
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Stenting + planned bowel resection or palliative care | Emergency bowel surgery | Relative (95% CI) | Absolute | ||
| Clinically successful bowel decompression, stent arm only – Palliative or curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none |
98/1194 (82%) | - | - | - | MODERATE | CRITICAL |
| Perforation rate, stent arm only – Palliative or curative intent | ||||||||||||
| 3 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none |
6/1234 (5%) | - | Risk 0.05 | 50 more per 1000 | MODERATE | IMPORTANT |
| Stoma rate - Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none |
46/994 (46%) |
82/119 (69%) | RR 0.67 (0.53 to 0.86) | 112 fewer per 1000 (from 22 fewer to 183 fewer) | MODERATE | IMPORTANT |
CI: confidence interval; HR: hazard ratio; RR: relative risk
- 1
Risk of bias assessed using trial protocol
- 2
Quality of evidence downgraded by 1 because of imprecision of the effect estimate (< 300 events for dichotomous outcomes or < 400 patients for continuous outcomes)
- 3
Numbers of events or participants were not reported
- 4
CREST results presented at ASCO 2016 meeting: Hill J, Kay C, Morton D et al J Clin Oncol 34, 2016 (suppl; abstr 3507)
Table 10Quality assessment of expert evidence – redacted outcomes (as yet unpublished)
| Quality assessment | No of patients | Effect | Quality | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No of studies | Design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Stenting + planned bowel resection or palliative care | Emergency bowel surgery | Relative (95% CI) | Absolute | ||
| 30-day mortality - Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | MODERATE | CRITICAL |
| 3-year overall survival, event is death from any cause - Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | MODERATE | IMPORTANT |
| Hospital stay (time to event analysis of leaving hospital)- Curative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | MODERATE | IMPORTANT |
| Hospital stay - Palliative intent | ||||||||||||
| 1 | randomised trials | no serious risk of bias1 | no serious inconsistency | no serious indirectness | serious2 | none | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | [REDACTED TEXT] | MODERATE | IMPORTANT |
CI: confidence interval; HR: hazard ratio; RR: relative risk
- 1
Risk of bias assessed using trial protocol
- 2
Quality of evidence downgraded by 1 because of imprecision of the effect estimate (< 300 events for dichotomous outcomes or < 400 patients for continuous outcomes)
- 3
Numbers of events or participants were not reported
Tables
Table 1Summary of the protocol (PICO table)
| Population |
Adults with acute large bowel obstruction caused by colorectal cancer or suspected colorectal cancer Subgroups:
|
|---|---|
| Intervention | Stenting followed by planned bowel resection or palliative care |
| Comparison |
|
| Outcomes | Critical
|
TNM: cancer classification system, standing for tumour, nodal and metastasis stages
Table 2Summary of included studies
| Study | Population | Interventions | Outcome | Comments |
|---|---|---|---|---|
| RCTs in patients treated with palliative intent | ||||
|
Dutch Stent-In-1 trial (Van Hooft 2008) RCT The Netherlands | N= 21 patients over the age of 18 years with incurable, left-sided colorectal cancer with a tumour that was localised between the splenic flexure and the proximal rectum (distal margin at least 10 cm from the anal verge). | Palliative stenting versus palliative surgery |
| Terminated early due to high number of serious adverse events in the treatment arm |
|
RCT Italy | N= 22 patients with advanced unresectable disease, peritoneal carcinomatosis and/or multiple parenchymatous metastatic disease. | Palliative stenting versus colostomy |
| N/A |
|
RCT Greece | N= 30 patients with partial inoperable malignant colonic obstruction | Palliative stenting versus colostomy |
| N/A |
|
RCT Australia | N= 52 patients ≥18 years who presented with a malignant large bowel obstruction, deemed not curable by surgical intervention | Palliative stenting versus emergency surgery |
| N/A |
| RCTs in patients treated with curative intent | ||||
|
RCT Spain | N= 28 patients over 18 years of age and a diagnosis of complete intestinal obstruction due to tumour in the left colon using an abdominal CT scan | SBTS versus emergency surgery |
| Suspended early due to excess morbidity in emergency surgery group |
|
RCT China | N= 48 patients aged >18 years presenting with clinical features of left colonic obstruction found between the splenic flexure and rectosigmoid junction | SBTS versus emergency surgery |
| N/A |
|
Dutch stent-In-2 trial (Van Hooft 2011; Sloothaak 2014) RCT The Netherlands | N= 98 patients aged ≥18 years, had clinical signs of severe left-sided, colonic obstruction that had existed for less than 1 week, and had dilation of the colon on either plain abdominal radiograph, with typical abnormalities on a gastrografin enema study, or contrast-enhanced CT scan. | SBTS versus emergency surgery |
| N/A |
|
RCT Italy | N= 115 patients with acute, symptomatic malignant left-sided large-bowel obstruction localised between the splenic flexure and 15 cm from the anal margin, as diagnosed by CT examination in the emergency room | SBTS versus emergency surgery |
| N/A |
|
RCT Egypt | N= 60 patients with acute left colonic obstruction confirmed by CT scan of the abdomen | SBTS versus emergency surgery |
| N/A |
|
RCT China | N= 60 patients presenting with acute left colonic obstruction confirmed by a computed tomography of the abdomen | SBTS versus emergency surgery |
| N/A |
|
Pirlet 2011 RCT France | N= 60 patients >18 years, fit for both emergency surgery and colonic stenting, and presenting with obstructive symptoms, dilation of the colon, and typical abnormalities confirmed by water-soluble contrast enema, CT scan, or findings at colonoscopy suggesting left-sided malignant obstruction. Tumour located between (including) the splenic flexure and the rectosigmoid junction | SBTS versus emergency surgery |
| Suspended early due to bowel perforation in the treatment arm |
CT: computed tomography; N: number; N/A: not applicable; RCT: randomised controlled trial; SBTS: stenting as a bridge to surgery
Final
Evidence reviews
Developed by the National Guideline Alliance part of the Royal College of Obstetricians and Gynaecologists
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