Dataset Information

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.

ABSTRACT: Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution.Multicenter (8 endoscopic referral centers), open-label, parallel, randomized clinical trial involving patients with treatment-naive, benign biliary strictures (N?=?112) due to orthotopic liver transplant (n?=?73), chronic pancreatitis (n?=?35), or postoperative injury (n?=?4), who were enrolled between April 2011 and September 2014 (with follow-up ending October 2015). Patients with a bile duct diameter less than 6 mm and those with an intact gallbladder in whom the cystic duct would be overlapped by a cSEMS were excluded.Patients (N?=?112) were randomized to receive multiple plastic stents or a single cSEMS, stratified by stricture etiology and with endoscopic reassessment for resolution every 3 months (plastic stents) or every 6 months (cSEMS). Patients were followed up for 12 months after stricture resolution to assess for recurrence.Primary outcome was stricture resolution after no more than 12 months of endoscopic therapy. The sample size was estimated based on the noninferiority of cSEMS to plastic stents, with a noninferiority margin of -15%.There were 55 patients in the plastic stent group (mean [SD] age, 57 [11] years; 17 women [31%]) and 57 patients in the cSEMS group (mean [SD] age, 55 [10] years; 19 women [33%]). Compared with plastic stents (41/48, 85.4%), the cSEMS resolution rate was 50 of 54 patients (92.6%), with a rate difference of 7.2% (1-sided 95% CI, -3.0% to ?; P?

SUBMITTER: Cote GA

PROVIDER: S-EPMC5544902 | biostudies-literature | 2016 Mar 22-29

REPOSITORIES: biostudies-literature

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Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.

Coté Gregory A GA Slivka Adam A Tarnasky Paul P Mullady Daniel K DK Elmunzer B Joseph BJ Elta Grace G Fogel Evan E Lehman Glen G McHenry Lee L Romagnuolo Joseph J Menon Shyam S Siddiqui Uzma D UD Watkins James J Lynch Sheryl S Denski Cheryl C Xu Huiping H Sherman Stuart S

JAMA 20160301 12

<h4>Importance</h4>Endoscopic placement of multiple plastic stents in parallel is the first-line treatment for most benign biliary strictures; it is possible that fully covered, self-expandable metallic stents (cSEMS) may require fewer endoscopic retrograde cholangiopancreatography procedures (ERCPs) to achieve resolution.<h4>Objective</h4>To assess whether use of cSEMS is noninferior to plastic stents with respect to stricture resolution.<h4>Design, setting, and participants</h4>Multicenter (8 ...[more]

PMID: 27002446

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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.

Dataset Information

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.

Publications

Effect of Covered Metallic Stents Compared With Plastic Stents on Benign Biliary Stricture Resolution: A Randomized Clinical Trial.

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