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A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures.

ABSTRACT: BACKGROUND AND STUDY AIMS?:Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant biliary obstruction. PATIENTS AND METHODS?:A prospective, randomized subject-blinded trial was conducted. Patients with malignant biliary obstruction were randomized (1:1) to either a 10 French winged stent or 7 or 10 French conventional plastic stent. Strictures greater than 1?cm distal to the hilum were included. Patients were followed clinically to determine the frequency of stent failure until surgery, death or study closure. RESULTS?:Fifty-eight patients were enrolled. Following 9 exclusions, 49 patients were randomized to a winged (n?=?23) or conventional stent (n?=?26). Median time to stent failure was 89 (95?% CI 26-NA) vs 143 (95?% CI 33?-?266) days ( P ?=?0.963) for the winged and conventional group, respectively. Stent failure for the winged group occurred in 11 (48?%) compared to 14 (54?%) in the conventional group.?Median survival was 123 (95?% CI 81?-?189) vs 342 days (95?% CI 123?-?704) (p?=?0.084) in the winged and conventional group respectively. There were no procedure related adverse events. CONCLUSIONS?:Improvement in stent patency was not seen with the winged stent when compared to the conventional plastic stent.

SUBMITTER: Ayres L

PROVIDER: S-EPMC5500122 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures.

Ayres Lachlan L Cheriyan Danny D Scott Ryan R Kim Edward E Lee Terry T Singer Joel J Donnellan Fergal F Byrne Michael M Weiss Alan A Enns Robert R Amar Jack J Lam Eric E Telford Jennifer J

Endoscopy international open 20170706 7

<h4>Background and study aims</h4>Stent insertion at endoscopic retrograde cholangiopancreatography (ERCP) is an established therapy for managing malignant biliary obstruction. Conventional plastic stents with a tubular design are most commonly used despite limited patency. Plastic stents with a winged design may theoretically increase the duration of stent patency. The aim of this study was to compare stent patency of the winged versus conventional plastic stents in patients with malignant bili ...[more]

PMID: 28691046

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Project description:BackgroundThe occurrence of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP) after using covered self-expandable metallic stents (CSEMS) and multiple plastic stents (MPS) in the therapy of benign biliary strictures (BBS) remains ambiguous, this analysis aimed to evaluate the outcomes.MethodsA systematic search of electronic databases (PubMed, Web of Science and Cochrane Library) was conducted for randomised controlled trials (RCTs), and the included studies were published between 2008 and 2021. The primary outcome was PEP, while the secondary outcomes were stricture resolution, recurrence, overall adverse events, costs, and ERCP sessions. Pooled effect sizes were calculated with the random-effects model or fixed-effects model depending on the heterogeneity.ResultsSix RCTs contained 444 patients (221 with CSEMS, 223 with MPS) finally included in the meta-analysis. The present analysis shows that compared to MPS, PEP is more likely to occur in CSEMS (OR [odds ratio] = 3.34, 95% confidence intervals [CI]:1.44-7.77, p = .005). CSEMS needs fewer ERCP sessions (Mean Deviation [MD]: -1.56; 95%CI:-2.66, -0.46], p = .006). The difference in stricture resolution and recurrence was not significant between the two stent types (OR = 0.87, 95%CI: 0.49-1.56, p = .64; and OR = 2.3, 95%CI: 0.68-7.76, p = .18). The incidence of overall adverse events was comparable between CSEMS and the MPS group (OR = 1.49, 95% CI: 0.97-2.29, p = .07).ConclusionsCompared with MPS, CSEMS caused a significantly higher incidence of PEP but fewer ERCP procedures, while the rate of stricture resolution, recurrence, and overall adverse events were comparable. Prevention methods of PEP should be further evaluated in BBS when undergoing CSEMS placement.Systematic review registrationPROSPERO CRD42022314864. Key messagesCSEMS and MPS placement remain a mainstay for patients with BBS, and severe complications after stent placement have not been compared.The incidence of PEP was higher after deployment of CSEMS compared to MPS.Prevention methods of PEP should be evaluated in BBS when undergoing CSEMS placement.

Project description:BackgroundMargin status is one of the most significant prognostic factors after curative surgery for middle bile duct (MBD) cancer. Bile duct resection (BDR) is commonly converted to pancreaticoduodenectomy (PD) to achieve R0 resection. Additionally, adjuvant treatment is actively performed after surgery to improve survival. However, the wider the range of surgery, the higher the chance of complications; this, in turn, makes adjuvant treatment impossible. Nevertheless, no definitive surgical strategy considers the possible complication rates and subsequent adjuvant treatment. We aimed to investigate the appropriate surgical type considering the margin status, complications, and adjuvant treatment in MBD cancer.Materials and methodsFrom 2008 to 2017, 520 patients diagnosed with MBD cancer at the Samsung Medical Center were analyzed retrospectively according to the operation type, margin status, complications, and adjuvant treatment. The R1 group was defined as having a carcinoma margin.ResultsThe 5-year survival rate for patients who underwent R0 and R1 resection was 54.4% and 33.3%, respectively (p = 0.131). Prognostic factors affecting the overall survival were the age, preoperative CA19-9 level, T stage, and N stage, but not the operation type, margin status, complications, or adjuvant treatment. The complication rates were 11.5% and 29.8% in the BDR and PD groups, respectively (p < 0.001). We observed no significant difference in the adjuvant treatment ratio according to complications (p = 0.675). Patients with PD who underwent R0 resection and could not undergo chemotherapy because of complications reported better survival rates than those with BDR who underwent R1 resection after adjuvant treatment (p = 0.003).ConclusionThe survival outcome of patients with R1 margins who underwent BDR did not match those with R0 margins after PD, even after adjuvant treatment. Due to improvements in surgical techniques and the ability to resolve complications, surgical complications exert a marginal effect on survival. Therefore, surgeons should secure R0 margins to achieve the best survival outcomes.

Dataset Information

A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures.

Publications

A randomized trial comparing winged versus conventional plastic stents for malignant bile duct strictures.

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