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

ABSTRACT: 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.

SUBMITTER: Bang JY

PROVIDER: S-EPMC6582745 | biostudies-literature |

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

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