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
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
Dig Endosc. 2025 Aug 6. doi: 10.1111/den.70010.
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).
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.
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.
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).
UMIN000049224.
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。
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。
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。
对于SAA和不可切除MBO患者，尤其是那些进行了Roux-en-Y重建的患者，EUS-BD可能是比BEA-ERCP更合适的主要引流方法（大学医院医学信息网络000049224）。
UMIN000049224。
