Abstract：
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], I2 = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I2 = 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], I2 = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I2 = 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.).
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], I2 = 35.34%) and PC-SEMSs (25.3% [95% CI, 20.2-30.7], I2 = 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], I2 = 63.1%) versus PC-SEMSs (369 days [95% CI, 290-449], I2 = 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.).
摘要：
目的：自膨式金属支架（SEMS）通常用于远端恶性胆道梗阻（dMBO）。虽然数据表明覆盖SEMS与未覆盖SEMS增加了复发性胆道梗阻(TRBO)的时间,完全覆盖(FC)与部分覆盖(PC)设计无可用数据。
方法：发布，截至2023年1月，对Scopus和Cochrane数据库进行了筛选，以进行有关通过FC或PC-SEMS治疗并描述不良事件（AE）的dMBO的研究。特定设计亚群的复发或TRBO。使用随机效应模型计算集合比例或平均值[95%置信区间]。几个子分析是预先计划的，包括一项仅限于前瞻性研究和不可切除的疾病。研究了异质性和出版偏倚。计算组间的标准化差异(d值)。
结果：来自1290条记录，62项研究（3327FC-SEMS，包括2322个PC-SEMS)。FC与PC-SEMS的总不良事件发生率差异可忽略不计(12%与9.9%)和所有特定的不良事件，包括胆囊炎(2.5%vs.2.6%）。在仅限于前瞻性研究和不可切除疾病的子分析中，RBO率在FC-SEMS之间相当(27.3%[23.7-31.2]，I2=35.34%）与PC-SEMS（25.3%[20.2-30.7]，I2=85.09%)，尽管有利于FC-SEMS的向内生长率（0.5％vs2.9％）和有利于PC-SEMS的迁移率（9.8％vs4.3％）差异很小（0.186-d值-0.216）。FC-SEMS的TRBO较短（238[191-286]天，I2=63.1%）与PC-SEMS（369[290-449]天，I2=71.9%；d值=0.116）。
结论：尽管存在相当大的异质性和较小的标准化差异，PC-SEMS在分析中始终表现出比FC-SEMS更长的TRBO，AE率没有任何其他差异，可能建议将PC-SEMS作为标准比较物，将TRBO作为未来dMBO随机研究的主要结局（CRD42023393965）。
方法：发布，截至2023年1月，对Scopus和Cochrane数据库进行了筛选，以进行有关通过FC或PC-SEMS治疗并描述不良事件（AE）的dMBO的研究。特定设计亚群的复发或TRBO。使用随机效应模型计算集合比例或平均值[95%置信区间]。几个子分析是预先计划的，包括一项仅限于前瞻性研究和不可切除的疾病。研究了异质性和出版偏倚。计算组间的标准化差异(d值)。
结果：来自1290条记录，62项研究（3327FC-SEMS，包括2322个PC-SEMS)。FC与PC-SEMS的总不良事件发生率差异可忽略不计(12%与9.9%)和所有特定的不良事件，包括胆囊炎(2.5%vs.2.6%）。在仅限于前瞻性研究和不可切除疾病的子分析中，RBO率在FC-SEMS之间相当(27.3%[23.7-31.2]，I2=35.34%）与PC-SEMS（25.3%[20.2-30.7]，I2=85.09%)，尽管有利于FC-SEMS的向内生长率（0.5％vs2.9％）和有利于PC-SEMS的迁移率（9.8％vs4.3％）差异很小（0.186-d值-0.216）。FC-SEMS的TRBO较短（238[191-286]天，I2=63.1%）与PC-SEMS（369[290-449]天，I2=71.9%；d值=0.116）。
结论：尽管存在相当大的异质性和较小的标准化差异，PC-SEMS在分析中始终表现出比FC-SEMS更长的TRBO，AE率没有任何其他差异，可能建议将PC-SEMS作为标准比较物，将TRBO作为未来dMBO随机研究的主要结局（CRD42023393965）。
