Background and Aims

ERCP-guided biliary drainage (ERCP-BD) is a criterion standard treatment for malignant biliary obstruction when curative surgery is not an option. Alternative methods such as percutaneous transhepatic biliary drainage would significantly lower the quality of life. EUS-guided biliary drainage (EUS-BD) has been developed and performed by experienced endoscopists. Therefore, the aims of this study were to evaluate the efficacy and safety of EUS-BD compared with ERCP in malignant biliary obstruction.

Methods

The prospective randomized controlled study was conducted, and 30 patients were enrolled: 15 for each EUS-BD and ERCP-BD arms. The technical success, procedural time, clinical success, and adverse events were evaluated.

Results

Thirty patients had extrahepatic malignant biliary tract obstruction (19 men, 11 women). Twenty-seven patients had unresectable pancreatic ductal adenocarcinomas, 1 patient had distal common bile duct cancer, and 2 patients had metastatic malignant lymphadenopathy. There were no significant differences both in terms of technical success rate and clinical success rate (100% vs 93% and 93% vs 100% in ERCP-BD vs EUS-BD, respectively; P = 1.00, P = 1.00). Four patients (31%) had tumor ingrowth–caused stent dysfunction in the ERCP-BD group, whereas 2 patients had food impaction and 2 patients had stent migration in the EUS-BD group. No significant procedure-related adverse events occurred in either group.

Conclusions

This prospective randomized controlled study suggests that EUS-BD has similar safety to ERCP-BD. EUS-BD was not superior to ERCP-BD in terms of relief of malignant biliary obstruction. EUS-BD may have fewer cases of tumor ingrowth but may also have more cases of food impaction or stent migration. (Clinical trial registration number: NCT01421836.)

中文翻译：

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EUS指导和ERCP指导的胆道引流治疗恶性胆道梗阻的疗效：前瞻性随机对照研究

背景和目标

当无法进行根治性手术时，ERCP引导的胆汁引流（ERCP-BD）是恶性胆道梗阻的标准治疗标准。诸如经皮经肝胆道引流的替代方法将大大降低生活质量。EUS引导的胆汁引流（EUS-BD）已由经验丰富的内镜医师开发和执行。因此，本研究的目的是评估EUS-BD与ERCP相比在恶性胆道梗阻中的疗效和安全性。

方法

进行了一项前瞻性随机对照研究，招募了30例患者：每个EUS-BD和ERCP-BD臂15例。评估技术成功，手术时间，临床成功和不良事件。

结果

肝外恶性胆道梗阻30例（男19例，女11例）。27例不可切除的胰管腺癌，1例远端胆总管癌，2例转移性恶性淋巴结病。在技​​术成功率和临床成功率方面均无显着差异（ERCP-BD与EUS-BD分别为100％对93％和93％对100％；P  = 1.00，P  = 1.00）。ERCP-BD组中有4例患者（31％）因肿瘤向内生长而导致支架功能异常，而EUS-BD组中有2例患者因食物受累而2例患者发生了支架移位。两组均未发生与手术相关的重大不良事件。

结论

这项前瞻性随机对照研究表明，EUS-BD与ERCP-BD具有相似的安全性。在缓解恶性胆道梗阻方面，EUS-BD并不优于ERCP-BD。EUS-BD的肿瘤向内生长的病例可能较少，但食物撞击或支架移位的病例也可能较多。（临床试验注册号：NCT01421836。）