球囊小肠镜辅助内镜逆行胰胆管造影术与内镜超声引导下胆管引流术治疗解剖结构改变患者不可切除性恶性胆管梗阻的多中心前瞻性注册研究

Balloon Enteroscopy-Assisted ERCP Versus Endoscopic Ultrasound-Guided Biliary Drainage for Unresectable Malignant Biliary Obstruction in Patients With Surgically Altered Anatomy: A Multicenter Prospective Registration Study.

作者信息

Itonaga Masahiro, Takenaka Mamoru, Ikezawa Kenji, Ikeura Tsukasa, Shimatani Masaaki, Asada Masanori, Fujimori Nao, Sagami Ryota, Ogura Takeshi, Imai Hajime, Matsumoto Kazuyuki, Shintani Shuhei, Shiomi Hideyuki, Hatamaru Keiichi, Minaga Kosuke, Takada Ryoji, Wan Ke, Shimokawa Toshio, Kitano Masayuki

机构信息

Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.

出版信息

Dig Endosc. 2025 Aug 6. doi: 10.1111/den.70010.

DOI:10.1111/den.70010

PMID:40770675

Abstract

BACKGROUND AND AIMS

The present prospective multicenter clinical trial compared the efficacy and safety of balloon enteroscopy-assisted endoscopic retrograde cholangiopancreatography (BEA-ERCP) and endoscopic ultrasound-guided biliary drainage (EUS-BD) as primary drainage methods for patients with surgically altered anatomy (SAA) and unresectable malignant biliary obstruction (MBO).

METHODS

Technical and clinical success rates, procedure time, adverse events (AEs), and time to recurrent biliary obstruction (TRBO) were compared. Risk factors associated with technical failure were evaluated, and subgroup analysis investigating whether Roux-en-Y reconstruction affected the technical success rate was also performed.

RESULTS

Patient characteristics were comparable between the BEA-ERCP (n = 54) and EUS-BD (n = 44) groups. Compared with the BEA-ERCP group, the EUS-BD group had a significantly higher technical success rate, a significantly shorter procedure time, comparable rates of clinical success and AEs, and comparable TRBO. Multivariate analysis showed that BEA-ERCP was an independent predictor of technical failure. Subgroup analysis revealed that the technical success rate was significantly higher with EUS-BD than with BEA-ERCP in patients with Roux-en-Y reconstruction, with no significant difference in those without Roux-en-Y reconstruction.

CONCLUSIONS

EUS-BD may be a more suitable primary drainage method than BEA-ERCP for patients with SAA and unresectable MBO, especially those with Roux-en-Y reconstruction (University Hospital Medical Information Network 000049224).

TRIAL REGISTRATION

UMIN000049224.

摘要

背景与目的

本前瞻性多中心临床试验比较了气囊小肠镜辅助内镜逆行胰胆管造影术（BEA-ERCP）和内镜超声引导下胆道引流术（EUS-BD）作为手术改变解剖结构（SAA）和不可切除恶性胆道梗阻（MBO）患者的主要引流方法的疗效和安全性。

方法

比较技术成功率和临床成功率、操作时间、不良事件（AE）以及胆道梗阻复发时间（TRBO）。评估与技术失败相关的危险因素，并进行亚组分析以研究Roux-en-Y重建是否影响技术成功率。

结果

BEA-ERCP组（n = 54）和EUS-BD组（n = 44）的患者特征具有可比性。与BEA-ERCP组相比，EUS-BD组的技术成功率显著更高，操作时间显著更短，临床成功率和AE发生率相当，TRBO相当。多变量分析显示BEA-ERCP是技术失败的独立预测因素。亚组分析显示，在进行Roux-en-Y重建的患者中，EUS-BD的技术成功率显著高于BEA-ERCP，而在未进行Roux-en-Y重建的患者中无显著差异。