Calo Natalia Causada, Bishay Kirles, Yaghoobi Mohammad, Yuan Yuhong, Mosko Jeffrey, May Gary, Chen Yen-I, Teshima Christopher
Division of Gastroenterology, The Ottawa Hospital, University of Ottawa, Ottawa, Ontario, Canada.
Division of Gastroenterology, St. Michael's Hospital, University of Toronto, Toronto, Ontario, Canada.
J Can Assoc Gastroenterol. 2021 Aug 7;5(2):68-78. doi: 10.1093/jcag/gwab024. eCollection 2022 Apr.
Plastic 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.
A 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 statistic. Subgroup and sensitivity analyses were performed. The quality of the evidence was assessed using Grading of Recommendations, Assessment, Development and Evaluations (GRADE).
Nine 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; = 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; = 71%). There was no difference in technical failure (OR 1.06; 0.19, 6.00; = 12%).
LAMS/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.
塑料支架（PS）、管腔贴壁金属支架（LAMS）和双翼金属支架（BFMS）用于胰腺壁内坏死（WON）的初始引流。没有充分证据支持LAMS/BFMS优于PS，既往的系统评价缺乏比较分析，也缺乏关于WON疗效结果的试验数据和观察性研究。本研究旨在比较LAMS/BFMS与PS治疗胰腺WON患者的疗效和不良事件（AE）。
进行了截至2020年12月1日的全面检索。主要结局是引流后的临床改善。次要结局包括AE和技术失败。采用随机效应模型报告合并比值比（OR）及95%置信区间（CI）。用Cochrane统计量评估异质性。进行亚组分析和敏感性分析。采用推荐分级、评估、制定与评价（GRADE）对证据质量进行评估。
纳入9项研究（1项随机对照试验和8项观察性研究）用于主要结局，包括493例接受LAMS/BFMS治疗的患者和514例接受PS治疗的患者。与PS相比，LAMS/BFMS临床改善的几率更高（OR 2.58；95%CI 1.81，3.68；P = 1%）。这种关联在敏感性分析中仍然显著。使用LAMS/BFMS与更高的AE发生率无关（OR 1.22；0.61，2.46；P = 71%）。技术失败方面无差异（OR 1.06；0.19，6.00；P = 12%）。
与PS相比，LAMS/BFMS治疗胰腺WON患者似乎能带来更好的临床结局，AE和技术失败情况相当。有必要进行更大规模的随机对照试验来进行此比较。
