Pancreatobiliary Endoscopy and Endosonography Division, Pancreas Translational and Clinical Research Centre, IRCCS San Raffaele Scientific Institute, Vita-Salute San Raffaele University, Milan, Italy.
Gastroenterology Department, Morgagni-Pierantoni Hospital, Forlì, Italy.
Gastrointest Endosc. 2024 Mar;99(3):314-322.e19. doi: 10.1016/j.gie.2023.10.023. Epub 2023 Oct 7.
Self-expandable metal stents (SEMSs) are standardly used for distal malignant biliary obstruction (dMBO). Although data suggest that covered versus uncovered SEMSs increase the time to recurrent biliary obstruction (TRBO), no data are available for fully covered (FC) versus partially covered (PC) designs.
PubMed, Scopus, and Cochrane databases were screened up to January 2023 for studies concerning dMBO treated by an FC- or PC-SEMS and describing adverse events (AEs), recurrences, or TRBO for specific design subpopulations. Pooled proportions or means were calculated using a random-effects model. Several subanalyses were preplanned, including a subanalysis restricted to prospective studies and unresectable diseases. Heterogeneity and publication bias were explored. Standardized differences (d-values) were calculated between groups.
From 1290 records, 62 studies (3327 using FC-SEMSs and 2322 using PC-SEMSs) were included. FC- versus PC-SEMSs showed negligible differences in the rate of total AEs (12% vs 9.9%) and all specific AEs, including cholecystitis (2.5% vs 2.6%). In a subanalysis restricted to prospective studies and unresectable diseases, the rate of RBO was comparable between FC-SEMSs (27.3% [95% confidence interval {CI}, 23.7-31.2], I = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I = 85.09%), despite small differences (d-values between .186 and .216) in the rate of ingrowth (.5% vs 2.9%) favoring FC-SEMSs and migration (9.8% vs 4.3%) favoring PC-SEMSs. TRBO was shorter for FC-SEMSs (238 days [95% CI, 191-286], I = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I = 71.9%; d-value = .116).
Despite considerable heterogeneity and small standardized differences, PC-SEMSs consistently exhibited longer TRBO than FC-SEMSs across analyses, without any other differences in AE rates, potentially proposing PC-SEMSs as the standard comparator and TRBO as the primary outcome for future randomized studies on dMBO. (Clinical trial registration number: CRD42023393965.).
自膨式金属支架（SEMS）是治疗远端恶性胆道梗阻（dMBO）的标准方法。虽然有数据表明，覆膜与非覆膜 SEMS 可延长复发性胆道梗阻（TRBO）的时间，但对于完全覆膜（FC）与部分覆膜（PC）设计尚无数据。
检索 PubMed、Scopus 和 Cochrane 数据库，截至 2023 年 1 月，查找关于 FC-或 PC-SEMS 治疗 dMBO 并描述特定设计亚组不良事件（AE）、复发或 TRBO 的研究。使用随机效应模型计算汇总比例或平均值。进行了几项亚分析，包括仅限于前瞻性研究和不可切除疾病的亚分析。探索了异质性和发表偏倚。计算了组间的标准化差异（d 值）。
从 1290 条记录中，纳入了 62 项研究（3327 例使用 FC-SEMS，2322 例使用 PC-SEMS）。FC-SEMS 与 PC-SEMS 的总 AE 发生率（12%与 9.9%）和所有特定 AE 发生率（包括胆囊炎，2.5%与 2.6%）差异较小。在仅限于前瞻性研究和不可切除疾病的亚分析中，FC-SEMS 的 RBO 发生率（27.3%[95%置信区间{CI}，23.7-31.2]，I=35.34%）与 PC-SEMS（25.3%[95%CI，20.2-30.7]，I=85.09%）相当，尽管在植入物生长（0.5%比 2.9%，有利于 FC-SEMS）和迁移（9.8%比 4.3%，有利于 PC-SEMS）方面存在较小差异（d 值在 0.186 至 0.216 之间）。FC-SEMS 的 TRBO 较短（238 天[95%CI，191-286]，I=63.1%），而 PC-SEMS 较长（369 天[95%CI，290-449]，I=71.9%；d 值为 0.116）。
尽管存在较大的异质性和较小的标准化差异，但在所有分析中，PC-SEMS 的 TRBO 始终长于 FC-SEMS，AE 发生率无差异，这可能提示 PC-SEMS 是未来关于 dMBO 的随机研究的标准对照，TRBO 是主要结局。（临床试验注册号：CRD42023393965.）。
