Project description:BackgroundEndoscopic ultrasonography (EUS)-guided drainage has become the first-line therapy for late peri-pancreatic fluid collection (PFC). Double pigtail plastic stents (DPPS) and lumen-apposing metal stents (LAMS) are commonly used for PFC drainage. Recently, a multi-institutional consensus on PFC drainage has recommended that LAMS should be the standard care for patients with walled-off necrosis (WON). However, given the poor quality of evidence, we aim to perform a large-scale randomized controlled trial to determine whether LAMS is superior to DPPS for WON drainage.Methods/designThe study is an open-label, prospective, parallel-group, superiority, multicenter randomized controlled trial. Two hundred and fifty-six patients with WON who will attend 18 tertiary hospitals in China will be randomly allocated to the LAMS or DPPS group before the procedure. The primary endpoint is the clinical success at one month after drainage (reduction in the size of WON to < 2 cm). Secondary endpoints include technical success, operation time, recurrence, adverse events, and secondary interventions.DiscussionThe LVPWON trial is designed to determine whether LAMS is effective, safe, and superior to DPPS for WON drainage.Trial registrationClinicalTrials.gov, NCT03027895 . Registered on 14 January 2017.

| S-EPMC6180448 | biostudies-literature

Drainage of gastric intramural abscesses using lumen-apposing metal stents.

Project description:Video 1Decompression of gastric intramural abscesses using LAMS.

| S-EPMC8430045 | biostudies-literature

A simple method to reposition a dislocated lumen-apposing metal stent during endoscopic necrosectomy.

Project description: Not available

| S-EPMC7805129 | biostudies-literature

Placement of Plastic Stents after Direct Endoscopic Necrosectomy through a Novel Lumen-Apposing Metal Stent for Effective Treatment of Laterally Extended Walled-Off Necrosis: A Pilot Study.

Project description:Direct endoscopic necrosectomy (DEN) using a lumen-apposing metal stent (LAMS) is a standard therapy for the management of symptomatic walled-off necrosis (WON). Here, we demonstrated the efficacy of the routine placement of long plastic stents after a DEN session to treat laterally extended WON. Patients (n = 6) with symptomatic laterally extended WON who underwent DEN after long plastic stent placement were included. The primary endpoint was clinical efficacy of the procedure. The technical and clinical success rates were 100% without major adverse events. The WON extended to the pelvic cavity or pericolic area, and the WON size was between 18.6 and 35.8 cm in length. The median number of DEN sessions was 10 (range 6-16), and two or three long plastic stents were placed after every DEN session. Only one patient suffered from pneumoperitoneum during DEN, which spontaneously resolved within 20 min. Placement of a long plastic stent after DEN using LAMS is a minimally invasive and effective treatment for symptomatic laterally extended WON. Further studies are needed to define the indications and most suitable patients.

| S-EPMC9917419 | biostudies-literature

Intraperitoneal salvage of an EUS-guided gastroenterostomy using a nested lumen-apposing metal stent.

Project description: Not available

| S-EPMC7482363 | biostudies-literature

Endoscopic retrieval of a buried lumen-apposing metal stent through an indwelling lumen-apposing metal stent.

Project description: Not available

| S-EPMC6004339 | biostudies-literature

Non-superiority of lumen-apposing metal stents over plastic stents for drainage of walled-off necrosis in a randomised trial.

Project description:OBJECTIVE:Although lumen-apposing metal stents (LAMS) are increasingly used for drainage of walled-off necrosis (WON), their advantage over plastic stents is unclear. We compared efficacy of LAMS and plastic stents for WON drainage. DESIGN:Patients with WON were randomised to endoscopic ultrasound-guided drainage using LAMS or plastic stents. Primary outcome was comparing total number of procedures to achieve treatment success defined as symptom relief in conjunction with WON resolution on CT at 6 months. Secondary outcomes were treatment success, procedure duration, clinical/stent-related adverse events, readmissions, length of hospital stay (LOS) and costs. RESULTS:60 patients underwent LAMS (n=31) or plastic stent (n=29) placement. There was no significant difference in total number of procedures performed (median 2 (range 2-7) LAMS vs 3 (range 2-7) plastic, p=0.192), treatment success, clinical adverse events, readmissions, LOS and overall treatment costs between cohorts. Although procedure duration was shorter (15 vs 40 min, p<0.001), stent-related adverse events (32.3% vs 6.9%, p=0.01) and procedure costs (US$12 155 vs US$6609, p<0.001) were higher with LAMS. Significant stent-related adverse events were observed ≥3 weeks postintervention in LAMS cohort. Interim audit resulted in protocol amendment where CT scan was obtained at 3 weeks postintervention followed by LAMS removal if WON had resolved. After protocol amendment, there was no significant difference in adverse events between cohorts. CONCLUSION:Except for procedure duration, there was no significant difference in treatment outcomes between LAMS and plastic stents. To minimise adverse events with LAMS, patients should undergo follow-up imaging and stent removal at 3 weeks if WON has resolved. TRIAL REGISTRATION NUMBER:NCT02685865.

| S-EPMC6582745 | biostudies-literature

Comparative Effectiveness of Lumen-Apposing Metal Stents and Plastic Stents for the Treatment of Pancreatic Walled-Off Necrosis: A Meta-analysis.

Project description:BackgroundPlastic stents (PS), lumen-apposing metal stents (LAMS) and biflanged metal stents (BFMS) are used for initial drainage of pancreatic walled-off necrosis (WON). There are no strong evidence to support the use of LAMS/BFMS over PS, and prior systematic reviews lack comparative analyses and also lack both trial data and observational studies for WON efficacy outcomes. The aim of this study is to compare the efficacy and adverse events (AEs) in LAMS/BFMS versus PS in patients with pancreatic WON.MethodsA comprehensive search up to December 1, 2020, was performed. The primary outcome was clinical improvement after drainage. Secondary outcomes included AEs and technical failure. Pooled odds ratios (OR) with 95% confidence intervals (CI) were reported using random effects models. Heterogeneity was evaluated with the Cochrane I 2 statistic. Subgroup and sensitivity analyses were performed. The quality of the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE).ResultsNine studies (one randomized controlled trial and eight observational) were included for the primary outcome including 493 patients treated with LAMS/BFMS and 514 with PS. LAMS/BFMS were associated with higher odds of clinical improvement compared with PS (OR 2.58; 95% CI 1.81, 3.68; I 2 = 1%). This association remained robust in sensitivity analyses. The use of LAMS/BFMS was not associated with higher AEs (OR 1.22; 0.61, 2.46; I 2 = 71%). There was no difference in technical failure (OR 1.06; 0.19, 6.00; I 2 = 12%).ConclusionsLAMS/BFMS seem to result in better clinical outcomes compared with PS in patients with pancreatic WON, with comparable AEs and technical failure. Larger randomized controlled trials for this comparison are warranted.

| S-EPMC8972216 | biostudies-literature

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