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Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial.

ABSTRACT: BACKGROUND:Endoscopic 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/DESIGN:The 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

SUBMITTER: Zhu HY

PROVIDER: S-EPMC6180448 | biostudies-literature | 2018 Oct

REPOSITORIES: biostudies-literature

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Project description:Background and aimsPelvic fluid collections (PFCs) are frequent adverse events of abdominal surgery or inflammatory conditions. A percutaneous approach to deep PFCs could be challenging and result in a longer, painful recovery. The transvaginal approach has been considered easy but is limited by the difficulty of leaving a stent in place. The transrectal approach has been described, but issues related to fecal contamination were hypothesized. Data on EUS-guided transrectal drainage (EUS-TRD) with lumen-apposing metal stents (LAMSs) are few and suggest unsatisfactory outcomes. The aim of this study was to evaluate the safety and efficacy of EUS-TRD with LAMSs in patients with PFCs.MethodsA retrospective analysis of a prospectively maintained database on therapeutic EUS was conducted. All EUS-TRD procedures were included.ResultsFive patients (2 male, age 44-89 years) were included. Four patients had postoperative PFCs, and 1 presented with a pelvic abscess complicating acute diverticulitis. Two of 5 had fecal diversion; the remaining 3 had unaltered large-bowel anatomy. One case had a concomitant abdominal collection, treated with percutaneous drainage in the same session. An electrocautery-enhanced LAMS delivery system (15 × 10 mm) was used in all cases. EUS-TRD was performed with the direct-puncture technique and lasted less than 10 minutes in 4 cases; in the remaining case, needle puncture and LAMS placement over a guidewire was required, and the procedure length was 14 minutes. The clinical success rate was 100%. LAMSs were removed after a median of 14 (range, 12-24) days. One patient reported partial proximal LAMS migration after 24 days (mild adverse event). No PFC recurrence was observed.ConclusionEUS-TRD with LAMSs is a safe and effective technique for treatment of PFCs. The use of 15- × 10-mm LAMSs allows rapid PFC resolution. EUS-TRD could be performed not only in patients with fecal diversion but also in cases of unaltered anatomy.

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Lumen-apposing metal stents (LAMS) versus plastic stents for EUS-guided drainage of walled-off necrosis (WON) (LVPWON): study protocol for a multicenter randomized controlled trial.

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