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Similar efficacy and safety of EUS-guided biliary drainage via hepaticogastrostomy and choledochoduodenostomy approaches for malignant distal biliary stenosis: a multicenter prospective randomized trial
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Kosuke Minaga1,
Takeshi Ogura2,
Masayuki Kitano3 |
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1Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, 2Second Department of Internal Medicine, Osaka Medical College, 3Second Department of Internal Medicine, Wakayama Medical University |
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| Aim: EUS-guided biliary drainage can be performed via two major different approaches: choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS). The present study aimed to compare the efficacy and safety of CDS and HGS in patients with inoperable malignant distal biliary stenosis after failed ERCP in a randomized controlled trial. Methods: Patients with distal biliary stenosis after failed ERCP were randomly assigned to treatment with CDS or HGS. The procedures were performed at nine institutions from September 2013 to March 2016. The primary endpoint was technical success rate, and the non-inferiority of HGS to CDS was examined. The secondary endpoints were clinical success, procedure time, adverse events, and stent patency. Results: 47 patients (HGS; 24, CDS; 23) were enrolled. The primary technical success rates were 87.5% in the HGS group and 82.6% in the CDS group (lower limit of the 90% confidence interval = -12.2%, one-sided P = 0.0278 for a non-inferiority margin of 15%). The clinical success rates were 100% in the HGS group and 94.7% in the CDS group (P = 0.475). The incidence rates of early and late procedure-related adverse events were similar. The mean procedure time was longer in the HGS group than in the CDS group (P = 0.0170). The median stent patency period was similar (144 days in the HGS group vs. 104 days in the CDS group, log-rank P = 0.670). Conclusions: EUS-guided biliary drainage via CDS and HGS had similar efficacy and safety in patients with malignant distal biliary stenosis after failed ERCP. |
Index Term 1: EUS-guided biliary drainage
Index Term 2: malignant biliary stenosis |
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