Abstract

Walled-off necrosis (WON) is a severe complication of pancreatitis with a high risk of infection or death. Symptomatic WON has typically been treated by drainage using double-pigtail plastic stents (DPPS). More recently, lumen-apposing metal stents (LAMS) were introduced with the intention of improving drainage of solid necrosis and allowing through-the-LAMS necrosectomy. Prior studies have reported similar efficacy of LAMS and DPPS for the treatment of WON. However, some small studies have suggested that LAMS are associated with an increased risk of bleeding compared to DPPS for the treatment of WON. Our primary aim was to conduct a systematic review and meta-analysis to compare the most widely used LAMS to DPPS for WON drainage, with an emphasis on stent-related safety outcomes. Our secondary aim was to document safety and efficacy outcome definitions across studies. Studies were identified from a published 2018 meta-analysis and from searches of the Ovid EBM Reviews (Embase, MEDLINE, Cochrane) and Scopus databases through October 9, 2019. Randomized controlled trials (RCT), cohort studies, case-control studies, and case series that assessed the AXIOS LAMS (Boston Scientific, Marlborough, MA) or DPPS for WON drainage were reviewed. Studies were excluded if they did not use the 2012 Atlanta criteria for WON diagnosis, if they used surgical or percutaneous drainage, reported interim study results, reported on ≤5 patients, or had overlapping study populations. Quality was assessed using the Newcastle Ottawa Scale. Safety and efficacy outcomes were assessed using a random-effects meta-analysis to estimate the proportion of patients with the measure or mean of the measure. Heterogeneity was assessed across studies using the I2 statistic. Data from 2053 patients who participated in 37 observational studies and one RCT were analyzed. Bleeding (4.3% vs. 12.1%, P=0.003; Figure 1) and perforation risk (2.1% vs. 4.3%, P=0.045) were found to be lower in the LAMS group than in the DPPS group. Similar numbers of procedures to achieve resolution (2.09 vs. 1.83, P=0.64) and similar rates of WON resolution (86.4% vs. 82.0%, P=0.20; Figure 2), stent migration (7.8% vs. 6.1%, P=0.54) and stent occlusion (6.2% vs. 13.2%, P=0.086) were found for LAMS compared to DPPS. Outcome definitions differed and were inconsistently reported across studies. Compared with DPPS, the LAMS most commonly used for WON drainage was associated with decreased bleeding and perforation risk and a similar WON resolution rate. Outcome definitions were variable across studies, and only one randomized trial was identified. Additional randomized studies with consistent outcome definitions could better inform the clinical management of WON.Figure 2WON resolution in patients treated with LAMS vs. DPPSView Large Image Figure ViewerDownload Hi-res image Download (PPT)

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