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1. Stents before surgery
1.1. Review question: Is inserting a stent clinically and cost-effective before surgical treatment in people with renal or ureteric stones?
1.2. Introduction
Ureteric JJ stents are used in stone management to relieve obstruction and uncontrollable pain in the emergency setting. In the elective setting the rationale for their use before surgery is that they will improve stone fragment passage, reduce complications, and reduce readmissions. There is particular concern that shock wave lithotripsy (SWL) for larger stones will result in stone fragments failing to pass resulting in the need for ancillary procedures and that pre-stenting will reduce this risk. However JJ stents are known to have adverse effects, and significant “stent symptoms” (for example, frequency, haematuria and pain) affecting patients quality of life are seen in 80% of cases.
There are no national agreed guidelines to the use of stents before SWL and practice varies. This questions aims to address this variation in practice.
1.4. Clinical evidence
1.4.1. Included studies
Five randomised studies and two non-randomised studies were included in the review;2, 4, 35, 38, 50, 53, 70 these are summarised in Table 4 below. Evidence from these studies is summarised in the clinical evidence summary below (Table 4). All included studies compared stent placement followed by SWL to SWL alone. All RCTs were in the adult population. No RCT evidence was identified for children and young people, so the search was extended to non-randomised studies. Two non-randomised studies were identified for inclusion; 4, 38. See also the study selection flow chart in appendix C, study evidence tables in appendix D, forest plots in appendix E and GRADE tables in appendix H.
1.4.1.1. Heterogeneity
For the comparison of stent before SWL versus SWL alone in the adult, renal, 10-20mm strata, there was substantial heterogeneity between the studies when they were meta-analysed for the outcomes of stent symptoms (haematuria). Pre-specified subgroup analyses did not explain the heterogeneity. A random effects meta-analysis was therefore applied to these outcomes, and the evidence was downgraded for inconsistency in GRADE.
1.4.2. Excluded studies
See the excluded studies list in appendix I
1.4.3. Summary of clinical studies included in the evidence review
See appendix D for full evidence tables.
1.4.4. Quality assessment of clinical studies included in the evidence review
1.4.4.1. Adults, ureteric, 10-20mm
1.4.4.2. Adults, renal, 10-20mm
1.4.4.3. Adults, renal, >20 mm
1.4.4.4. Children, renal, <10mm
1.5. Economic evidence
1.5.1. Included studies
No relevant health economic studies were identified.
1.5.2. Excluded studies
One economic study relating to this review question was identified but was excluded due to methodological limitations. 29 These are listed in appendix I, with reasons for exclusion given.
See also the health economic study selection flow chart in appendix G.
1.5.3. Unit costs
The clinical review data identified compares inserting a stent prior to SWL, and then leaving the stent in until a few weeks after the SWL then removing. This is compared to SWL with no stent inserted.
This essentially means that there are three procedures in the stent arm; stent insertion, SWL, and stent removal, and only the SWL in the no stent arm. This will create a large cost difference between the two interventions of over £2,000.
1.6. Resource costs
The recommendations made in this review are not expected to have a substantial impact on resources.
1.7. Evidence statements
1.7.1. Clinical evidence statements
Adults, ureteric, 10-20mm
One study compared stent use before SWL to SWL alone in a population of adults with 10-20mm ureteric stones. There was no clinical difference between the groups in terms of stone-free state and fever (1 study; n=60). There was a clinical benefit of SWL alone in terms of retreatment, and in terms of all stent symptoms outcomes (dysuria, microscopic haematuria, gross haematuria) (1 study, n=60). The quality of the evidence ranged from Low to Very Low. The main reasons for downgrading evidence included risk of bias and imprecision.
Adult, renal, 10-20mm
Three studies compared stent use before SWL and SWL alone in a population of adults with 10-20mm renal stones. All the studies reported stone-free state, and the evidence showed no clinical difference between the two groups (3 studies; n=258). Evidence from single studies showed no clinical difference for the outcomes clinically insignificant fragments, clinically significant fragments, ancillary procedures and retreatment (1 study; n=58-120). Evidence from two studies also showed no clinical difference in terms of readmission (2 studies; n=200). In terms of adverse events, evidence demonstrated no clinical difference in terms of UTI and in terms of fever (1-2 studies; n=58-138). In terms of stent symptoms, there was no clinical difference between groups for the outcome haematuria (3 studies; n=258). There was a clinical benefit of SWL alone in terms of all other stent symptom outcomes (urgency, frequency, dysuria, nocturia) (1 study; n=80). The quality of the evidence ranged from Moderate to Very Low. The main reasons for downgrading evidence included risk of bias, imprecision and in some cases, inconsistency.
Adults, renal, >20mm
One study compared stent use before SWL to SWL alone in a population of adults with renal stones >20mm. There was no clinical difference between the groups in terms of stone-free state, fever and failed technology (1 study; n=38-400). There was a clinical benefit of stent before SWL in terms of retreatment (1 study, n=38). The quality of the evidence ranged from Moderate to Very Low. The main reasons for downgrading evidence included risk of bias, imprecision and in some cases, indirectness.
Children, renal, 10-20mm
One non-randomised study compared stent use before SWL to SWL alone in a population of children with 10-20mm renal stones. The evidence demonstrated a clinical benefit of stent before SWL in terms of stone-free state, retreatment, ancillary procedures, and dysuria (1 study, n=20). For the outcome haematuria, there was a clinical benefit of SWL alone (1 study; n=20). The quality of the evidence was Very Low. The main reasons for downgrading evidence included risk of bias and imprecision.
Children, renal, 10-20mm
One non-randomised study compared stent use before SWL to SWL alone in a population of children with staghorn renal stones. The evidence demonstrated a no clinical difference between the groups in terms of stone-free state (1 study; n=42). There was a clinical benefit of stent before SWL in terms of readmission, ancillary procedures, length of stay and major adverse events (sepsis) (1 study, n=42). The quality of the evidence was Very Low. The main reasons for downgrading evidence included risk of bias and imprecision.
1.7.2. Health economic evidence statements
- No relevant economic evaluations were identified.
1.8. The committee’s discussion of the evidence
1.8.1. Interpreting the evidence
1.8.1.1. The outcomes that matter most
The committee agreed that stone-free state, recurrence rate, use of healthcare services, kidney function, quality of life, failed technology, major adverse events, minor adverse events and stent symptoms were the outcomes that were critical for decision making. Pain was also considered as an important outcome.
Evidence was reported for stone-free state, recurrence rate, use of healthcare services, failed technology, major adverse events, minor adverse events and stent symptoms. There was no evidence for the critical outcomes of quality of life or kidney function, or for the important outcome pain.
No evidence was found that compared stent use to no stent for the surgery modalities of URS or PCNL. The only evidence found for inclusion used SWL as the treatment modality.
1.8.1.2. The quality of the evidence
For the majority of evidence in this review, the quality ranged from a GRADE rating of moderate to very low. This was due to a lack of blinding, presence of selection bias in terms of a lack of adequate randomisation and allocation concealment, resulting in a high risk of bias rating. Evidence was further downgraded due to the presence of imprecision for many of the outcomes, and inconsistency for one outcome. No outcomes were given a high quality rating.
1.8.1.3. Benefits and harms
Evidence for people with both symptomatic and asymptomatic stones was searched for; however no evidence was identified for the asymptomatic population. The committee therefore agreed that the recommendations should only apply to those with symptomatic stones.
Adults, ureteric, 10 to 20 mm
The committee considered very low to low quality evidence from one study with 60 participants and noted that there was no difference between the two groups, or a clinical benefit of no stent. There was no evidence of a clinical benefit of stent for any outcomes. The committee agreed that this demonstrated that there was no evidence that stents improve outcomes for participants, and may actually impede beneficial outcomes, demonstrated by more retreatments, and more stent related adverse events and symptoms. Having a stent in place during SWL may prevent the shocks reaching the stone and consequently more retreatments may be required. The committee therefore agreed that stenting should not be recommended for ureteric stones of 10-20mm. The committee’s opinion was that ureteric stones need to be treated more urgently compared to renal stones as large ureteric stones can block the kidney and can lead to obstructive uropathy within 2-6 weeks, therefore treatment needs to be completed within this time frame. The committee considered that in cases where SWL could not be done in a timely fashion, the use of a stent may be considered appropriate in individual circumstances.
Adults, renal, 10 to 20 mm
The committee considered very low to moderate quality evidence from three studies and noted that there was no clinical difference between those who had had a stent before SWL and those who had not for any outcomes apart from the stent symptoms outcomes. The committee agreed that this demonstrated that there was no benefit of stenting before SWL over not stenting, and discussed that given that stenting is associated with a number of stent related adverse events and symptoms, stenting should not be offered for this group of people.
Adults, renal, greater than 20 mm
The committee considered the evidence from one study of very low to moderate quality and noted that there was no difference between the groups for the stone-free state, minor adverse events and failed technology outcomes. There was a clinical benefit for the stent group in terms of retreatment rate, however the committee noted that this evidence was from a single study and was very imprecise. The committee further noted several concerns regarding the validity and applicability of this study. For instance, it was noted that it is unusual practice to perform SWL for renal stones of this size, and that this would not be done in the UK. The committee also noted that the number of shocks given per session was above the recommended limit, which also does not reflect UK practice. It was further noted that in order to tolerate this level of shocks, it is likely that this would have been performed under general anaesthesia, which is also a deviation from standard practice in the UK. Therefore, the committee agreed that this study does not reflect UK current practice and therefore may not be applicable to a UK population. It was also noted that following the surgical interventions review, there is no recommendation for SWL for this group of people.
There was no evidence for ureteric or renal stones less than 10 mm, and no evidence for ureteric stones greater than 20 mm. The committee agreed that stone size should not be specified in the recommendation for a number of reasons;
- For small renal stones, current standard practice is not to stent pre-treatment.
- For small ureteric stones, stenting is sometimes used in current practice for a variety of reasons (ongoing pain, obstruction, lack of access to emergency definite treatment), however as shown in the timing of surgery review, there is clinical benefit to primary intervention within 48 hours, therefore avoiding the use of stents. The committee wanted to further encourage best practice of treating with primary treatment rather than temporising with a stent.
- Ureteric stones greater than 20 mm are unlikely to be treated with SWL and therefore the recommendation would not apply to this group.
Overall, the committee agreed that although the evidence had been reviewed and presented by strata, the results demonstrated that the same recommendation should be made for all adults with either ureteric or renal stones of all sizes. This is because the recommendation would only apply to where SWL is being used anyway (which generally precludes large stones; >20mm), and would reinforce current or best practice in other groups (stents before surgery are not generally used in small renal stones, and treatment within 48 hours would preclude the use of stents before SWL). Therefore adding a size into the recommendation was not felt to be necessary. The committee agreed no evidence had been presented that would warrant recommending the use of stents prior to SWL for any of the strata.
Children and young people, renal, less than 10 mm
One small non-randomised comparative study of very low quality was identified. Although this evidence demonstrated potential clinical benefit of stenting before SWL in terms of stone-free state, retreatment rate, ancillary procedures the committee noted that there was very high risk of bias and serious and very serious imprecision in the outcomes. The committee noted that this was likely due to the unequal distribution of lower pole stones in each arm (3/10 lower pole stones in stent group versus 7/10 lower pole stones non-stented group). These stones are more difficult to treat, and therefore the committee agreed that the differences between groups in stone-free state, retreatment rate and ancillary procedures are likely to be due to this difference in stone location. The committee were also aware that although the mean stone size of the participants was less than 10mm, the maximum stone size was 16mm and so some of this evidence included participants in the 10-20mm population. The committee further noted that this evidence was not consistent with clinical experience as stents would not normally inserted before SWL in this population. Therefore, the committee did not have confidence in the evidence and decided not to make a recommendation for this stratum.
Children and young people, renal, staghorn
Evidence from one non-randomised comparative study demonstrated a clinical benefit of stenting before SWL in terms of readmission, ancillary procedures, length of stay and sepsis, and no clinical difference between groups in terms of stone-free state. The committee considered that the maximum number of shockwaves per session used in this study was high compared to standard practice in the UK, but noted that it was unclear how many participants received the maximum number of shocks. The committee noted that the evidence came from a single study of very low quality. However, it was noted that the reduction in readmission and ancillary procedures were of particular benefit for the paediatric population. Based on this evidence, clinical experience and expertise of the committee, the consensus of the committee was that children with staghorn stones would generally derive benefit from having a stent and this would reflect usual practice, therefore it was agreed that stenting before SWL should be considered for children with a staghorn stone. The committee also noted that although SWL monotherapy is an option for paediatric staghorn calculi, many centres utilise PCNL as first line treatment for children with this type of stone.
No evidence was found for ureteric stones or for renal stones greater than 10 mm for children. The committee agreed that standard practice for children and young people is varied and so agreed that a consensus recommendation could not be made.
1.8.2. Cost effectiveness and resource use
One economic evaluation was identified but excluded because it was based on retrospective data and therefore considered to have very serious limitations, as this is not in keeping with the clinical review (for adults).
All the clinical review data identified compares inserting a stent prior to SWL, and then leaving the stent in until a few weeks after the SWL, then removing. This is compared to SWL with no stent inserted. This essentially means there are 3 procedures in the stent arm; stent insertion, SWL, and stent removal, and only the SWL in the no stent arm. This will create a large cost difference between the two interventions of over £2,000, as inserting or removing a stent comes under the same procedure code which has a cost of £1,018.
There were more stent symptoms with a stent which is to be expected. This will involve resource use such as patients possibly seeking healthcare advice such as GP time or hospital attendances, and being given pain relief and/or other drug treatments. For most outcomes there was no difference. Most outcomes are informed by only one study so it is difficult to have confidence in the results. However in general, if stents are a more expensive strategy and it is uncertain if there is any benefit but they do have more adverse events, then no stents are likely to be a dominant option if cheaper and equally effective.
The committee felt that there are two aspects to using stents; 1) if having an SWL, then does a stent stop the fragments getting stuck?, and 2) if there is an obstruction, should a stent be used to delay surgery?. It’s possible that this review can answer the first nuance, but not necessarily the second.
In the data identified for an adult ureteric population, there was a clinical benefit for no stent for retreatment, and also for stent symptoms. The committee thought that the stent may be impeding stone passage, which can sometimes happen, and might explain why more people needed retreatment in the stent group. This would lead to additional resource use of more interventions in the stent group, as well as more stent symptoms. The committee concluded that there was no convincing benefit to using stents and is also likely to be more costly.
In the adult renal stones population, data was identified for two strata; 10-20cm and >20cm. in the smaller stone group, the only outcome where there was a clinical benefit was of stent symptoms, again signalling that there is no benefit to stents but possible increased costs and quality of life impact. In the larger renal stone group, the committee had concerns about the quality of the paper with regards to the high frequency of shockwaves, and also that using SWL for this size stones was not in keeping with UK practice. There was only a clinical benefit of retreatment favouring the stent arm. This is in contrast to the result of the ureteric study where no stent led to lower retreatments. Perhaps with a larger stone the stent is helping the fragments to pass, or the increase in shockwave frequency compared to other studies has resulted in smaller fragments which can pass despite the stent. The study did not define the time frame it was reporting which may impact on outcomes such as retreatments. The committee did not feel confident making a recommendation based on this study.
The committee decided to make recommendations against using stents prior to SWL for both the ureteric and renal groups. As only data prior to SWL was identified, nothing can be said about stenting prior to other types of intervention. Kidney function can deteriorate irreversibly if left for up to 6 weeks with an obstruction, and so it is only safe to stent if treatment with SWL is available in a timely manner. In some areas, where a fixed site lithotripter is not available and patients have to wait for a mobile lithotripter, then it is a clinical decision whether the patient can safely wait for that period of time. If they cannot, then SWL is unlikely to be the appropriate intervention and surgery should be planned as soon as possible. Hence the population that cannot safely wait for SWL is a separate population that is not the intended population for these recommendations.
Stenting before SWL is not particularly common in UK practice at the moment (around 5% based on a recent UK audit (Doherty et al, 2017), however in areas where it might be, these recommendations are likely to be cost saving.
In children, only non-randomised evidence was identified. One study in children with renal stones had differing baseline characteristics which were thought to explain the results. One study relating to staghorn stones demonstrated that stenting pre SWL had a benefit with respect to readmission, ancillary procedures, and major adverse events. Readmission and ancillary procedures lead to higher resource use. The shockwave dose was thought to be high in this study. SWL monotherapy is an option for children with this type of stone. The committee reached a consensus that a consider recommendation should be made for stents in this group. A consider recommendation allows an element of clinician judgement. This population is small and therefore is unlikely to reach the resource impact threshold, even with full uptake.
1.8.3. Other factors the committee took into account
The only evidence available was for stenting pre SWL. The committee considered the availability of SWL and noted that most urology departments in the UK have access to SWL, but the majority use a mobile machine on a sessional basis. Therefore, the use of SWL for treatment of patients presenting acutely and within a timely fashion of that admission is mainly limited to units with a fixed site facility. For this reason, SWL is more routinely used for renal stones, where time to treatment is less critical.
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Appendices
Appendix A. Review protocols
Appendix B. Literature search strategies
The literature searches for this review are detailed below and complied with the methodology outlined in Developing NICE guidelines: the manual 2014, updated 2017 https://www.nice.org.uk/guidance/pmg20/resources/developing-nice-guidelines-the-manual-pdf-72286708700869
For more detailed information, please see the Methodology Review. [Add cross reference]
B.1. Clinical search literature search strategy
Searches were constructed using a PICO framework where population (P) terms were combined with Intervention (I) and in some cases Comparison (C) terms. Outcomes (O) are rarely used in search strategies for interventions as these concepts may not be well described in title, abstract or indexes and therefore difficult to retrieve. Search filters were applied to the search where appropriate.
B.2. Health Economics literature search strategy
Health economic evidence was identified by conducting a broad search relating to renal and ureteric stones population in NHS Economic Evaluation Database (NHS EED – this ceased to be updated after March 2015) and the Health Technology Assessment database (HTA) with no date restrictions. NHS EED and HTA databases are hosted by the Centre for Research and Dissemination (CRD). Additional searches were run on Medline and Embase for health economics studies.
Appendix C. Clinical evidence selection
Figure 2. Flow chart of economic study selection for the guideline
Appendix D. Clinical evidence tables
Download PDF (380K)
Appendix E. Forest plots
E.1. Adults, ureteric, 10-20mm
E.1.1. Stent followed by SWL versus SWL alone
Figure 5. Minor adverse events (fever)
E.2. Adults, renal, 10-20mm
E.2.1. Stent followed by SWL versus SWL alone
Figure 9. Clinically insignificant residual fragments
Figure 10. Clinically significant residual fragments
Figure 11. Readmission to hospital
Figure 13. Ancillary procedures
Figure 14. Minor adverse events (UTI)
Figure 15. Minor adverse events (fever)
Figure 16. Stent symptoms (urgency)
Figure 17. Stent symptoms (frequency)
Figure 18. Stent symptoms (haematuria)
E.3. Adults, renal, >20mm
E.3.1. Stent followed by SWL versus SWL alone
Figure 22. Minor adverse events (fever)
E.4. Children, renal, <10mm (non-randomised studies)
E.4.1. Stent followed by SWL versus SWL alone
Figure 27. Ancillary procedures
E.5. Children, renal, staghorn (non-randomised studies)
E.5.1. Stent followed by SWL versus SWL alone
Figure 31. Length of stay (days)
Appendix F. GRADE tables
F.1. Adults, ureteric, 10-20mm
Table 13. Clinical evidence profile: Stent followed by SWL versus SWL alone
F.2. Adults, renal, 10-20mm
Table 14. Clinical evidence profile: Stent followed by SWL versus SWL alone
F.3. Adults, renal, >20mm
Table 15. Clinical evidence profile: Stent followed by SWL versus SWL alone
F.4. Children, renal, 10-20mm
Table 16. Clinical evidence profile (non-randomised studies): Stent followed by SWL versus SWL alone
F.5. Children, renal, staghorn
Table 17. Clinical evidence profile (non-randomised studies): Stent followed by SWL versus SWL alone
Appendix G. Health economic evidence selection
Figure 35. Flow chart of economic study selection for the guideline
Appendix H. Health economic evidence tables
None
Appendix I. Excluded studies
I.1. Excluded clinical studies
I.2. Excluded health economic studies
Final
Intervention evidence review (H)
This evidence review was developed by the National Guideline Centre
Disclaimer: The recommendations in this guideline represent the view of NICE, arrived at after careful consideration of the evidence available. When exercising their judgement, professionals are expected to take this guideline fully into account, alongside the individual needs, preferences and values of their patients or service users. The recommendations in this guideline are not mandatory and the guideline does not override the responsibility of healthcare professionals to make decisions appropriate to the circumstances of the individual patient, in consultation with the patient and/or their carer or guardian.
Local commissioners and/or providers have a responsibility to enable the guideline to be applied when individual health professionals and their patients or service users wish to use it. They should do so in the context of local and national priorities for funding and developing services, and in light of their duties to have due regard to the need to eliminate unlawful discrimination, to advance equality of opportunity and to reduce health inequalities. Nothing in this guideline should be interpreted in a way that would be inconsistent with compliance with those duties.
NICE guidelines cover health and care in England. Decisions on how they apply in other UK countries are made by ministers in the Welsh Government, Scottish Government, and Northern Ireland Executive. All NICE guidance is subject to regular review and may be updated or withdrawn.
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- Do JJ Stents Increase the Effectiveness of Extracorporeal Shock Wave Lithotripsy for Pediatric Renal Stones?[Urol Int. 2017]Do JJ Stents Increase the Effectiveness of Extracorporeal Shock Wave Lithotripsy for Pediatric Renal Stones?Gündüz M, Sekmenli T, Ciftci İ, Elmacı AM. Urol Int. 2017; 98(4):425-428. Epub 2016 Oct 26.
- Ureteric stents vs percutaneous nephrostomy for initial urinary drainage in children with obstructive anuria and acute renal failure due to ureteric calculi: a prospective, randomised study.[BJU Int. 2015]Ureteric stents vs percutaneous nephrostomy for initial urinary drainage in children with obstructive anuria and acute renal failure due to ureteric calculi: a prospective, randomised study.ElSheemy MS, Shouman AM, Shoukry AI, ElShenoufy A, Aboulela W, Daw K, Hussein AA, Morsi HA, Badawy H. BJU Int. 2015 Mar; 115(3):473-9. Epub 2014 Oct 20.
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- Stents before surgeryStents before surgery
- AcetylationAcetylationFormation of an acetyl derivative. (Stedman, 25th ed)<br/>Year introduced: 1991(1973)MeSH
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