Cover of Effectiveness of stenting for acute large bowel obstruction

Effectiveness of stenting for acute large bowel obstruction

Colorectal cancer (update)

Evidence review C9

NICE Guideline, No. 151

Authors

.

London: National Institute for Health and Care Excellence (NICE); .
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.

Table 1. Summary of the protocol (PICO table).

Table 1

Summary of the protocol (PICO table).

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.

Table 2. Summary of included studies.

Table 2

Summary of included studies.

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 3. Review protocol for pharmacological treatments for spasticity

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

Database: Cochrane Library

Last searched on: 10/01/2019

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 1. Study 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 2. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - clinically successful bowel decompression - Palliative intent, stent arm only

Figure 3. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - clinically successful bowel decompression – curative intent, stent arm only

Figure 4. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - 30-day mortality – Palliative intent

Figure 5. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - 30-day mortality – Curative intent

Figure 6. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – disease free survival (follow up 4 to 5 years) – curative intent

Figure 7. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - progression free survival (follow–up 3 years) – Curative intent

Figure 8. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – overall survival – follow-up 1 to 5 years

Figure 9. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Anastomotic leak – palliative intent

Figure 10. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Anastomotic leak – curative intent

Figure 11. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - Perforation rate - Curative intent, stent arm only

Figure 12. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - surgical site infection – palliative intent

Figure 13. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - surgical site infection – curative intent

Figure 14. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - stoma rate

Figure 15. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - technical success – Palliative intent, stent arm only

Figure 16. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery – technical success – Curative intent, stent arm only

Figure 17. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery - stent failure – Curative intent, stent arm only

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 5. Comparison 1: Stenting followed by planned bowel resection or palliative care versus emergency surgery

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 6. Excluded studies and reasons for their exclusion

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