带或不带猪尾的管腔贴合支架在超声内镜引导下对恶性远端胆管梗阻进行胆管引流中的应用

Lumen-Apposing Stents With or Without Pigtail in Endosonography-Guided Biliary Drainage for Malignant Distal Biliary Obstruction.

作者信息

Sumalla-Garcia Albert, Aparicio-Tormo Jose R, Pedraza-Sanz Rafael, Sanchiz-Soler Vicente, De-la-Serna Higuera Carlos, Andujar Xavi, Vazquez-Sequeiros Enrique, Puigcerver-Mas Maria, Martinez-Moreno Belen, Barbera Tatiana, Capilla-Lozano Maria, Martinez-Ortega Antonio, Foruny-Olcina Jose Ramon, Luna-Rodriguez Daniel, Garcia-Lerma Esther, Peñafiel Judith, Busquets Barenys Juli, Laquente-Saez Berta, Perez-Miranda Manuel, Videla Sebastia, Loras Carme, Gornals Joan B

机构信息

Endoscopy Unit, Department of Digestive Diseases, Hospital Universitari de Bellvitge, Barcelona, Spain; Universitat de Barcelona, Barcelona, Spain; Bellvitge Biomedical Research Institute, Barcelona, Spain.

Endoscopy Unit, Department of Digestive Diseases, Hospital General Universitario Dr. Balmis de Alicante, Alicante, Spain.

出版信息

Clin Gastroenterol Hepatol. 2025 Jul 21. doi: 10.1016/j.cgh.2025.05.025.

DOI:10.1016/j.cgh.2025.05.025

PMID:40701486

Abstract

BACKGROUND & AIMS: Endoscopic ultrasound-guided biliary drainage, creating a choledochoduodenostomy and using lumen-apposing metal stents (LAMSs), is a promising intervention for the management of malignant distal biliary obstruction (MDBO). But concerns exist regarding its stent patency. Our aim was to determine whether the insertion of an axis-orienting double-pigtail plastic stent (DPS) through LAMS offered a clinical benefit by improving the stent dysfunction rate.

METHODS

This multicenter randomized controlled trial was carried out in 7 tertiary hospitals. Patients with MDBO secondary to resectable, locally advanced, or unresectable cancers, and indication for biliary drainage, were eligible for inclusion. Patients were randomly assigned (1:1) to either the LAMS group or the LAMS-DPS group. The primary endpoint was the rate of recurrent biliary obstruction (RBO), detected during follow-up. The secondary endpoints were technical and clinical success, safety, time to RBO, reinterventions, and hospitalization.

RESULTS

Between November 2020 and October 2022, we screened 123 patients with MDBO, of whom 91 were randomly assigned to LAMS (n = 47) or LAMS-DPS (n = 44). RBO rate was lower in the LAMS-DPS group (14 [30%] of 47 patients vs 4 [9%] of 44 patients; relative risk, 0.31; 95% confidence interval [CI], 0.09-0.78; P = .024). Hospitalization was shorter in the LAMS-DPS group (median difference, 4.5; 95% CI, 0-9; P = .016). The procedure time was longer (21 minutes vs 32 minutes; P = .018) in the LAMS-DPS group. No differences were found among technical, clinical success, and global adverse events (19 vs 27%; relative risk, 1.42; 95% CI, 0.67-3.18; P = .362).

CONCLUSIONS

In patients with MDBO, endoscopic ultrasound-guided biliary drainage using LAMS with coaxial DPS was superior to LAMS alone. It offered clinical benefits including lower recurrent biliary obstruction rate and shorter hospitalization.

CLINICALTRIALS

gov, Number: NCT04595058.

摘要

背景与目的

内镜超声引导下胆道引流、创建胆总管十二指肠吻合术以及使用管腔对合金属支架（LAMS）是治疗恶性远端胆管梗阻（MDBO）的一种有前景的干预措施。但其支架通畅性存在问题。我们的目的是确定通过LAMS置入轴向定向双猪尾塑料支架（DPS）是否能通过降低支架功能障碍率带来临床益处。

方法

这项多中心随机对照试验在7家三级医院开展。继发于可切除、局部晚期或不可切除癌症且有胆道引流指征的MDBO患者符合纳入标准。患者被随机分配（1:1）至LAMS组或LAMS-DPS组。主要终点是随访期间检测到的复发性胆管梗阻（RBO）率。次要终点包括技术和临床成功率、安全性、RBO发生时间、再次干预以及住院情况。

结果

在2020年11月至2022年10月期间，我们筛查了123例MDBO患者，其中91例被随机分配至LAMS组（n = 47）或LAMS-DPS组（n = 44）。LAMS-DPS组的RBO率更低（47例患者中有14例[30%]，44例患者中有4例[9%]；相对风险，0.31；95%置信区间[CI]，0.09 - 0.78；P = .024）。LAMS-DPS组的住院时间更短（中位数差异，4.5；95% CI，0 - 9；P = .016）。LAMS-DPS组的操作时间更长（21分钟对32分钟；P = .018）。在技术、临床成功率和总体不良事件方面未发现差异（19%对27%；相对风险，1.42；95% CI，0.67 - 3.18；P = .362）。