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Dig Endosc. 2019 Mar 25. doi: 10.1111/den.13406. [Epub ahead of print]

Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction: Multicenter, randomized, clinical trial.

Minaga K1,2,3, Ogura T1,4, Shiomi H1,5, Imai H1,2, Hoki N1,6, Takenaka M1,2,5, Nishikiori H1,7, Yamashita Y1,3, Hisa T1,8, Kato H1,9, Kamada H1,10, Okuda A1,4, Sagami R1,7, Hashimoto H1,6, Higuchi K1,4, Chiba Y1,11, Kudo M1,2, Kitano M1,2,12.

Author information

1
Therapeutic Endoscopic Ultrasound Group, Osaka, Japan.
2
Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan.
3
Department of Gastroenterology, Japanese Red Cross Wakayama Center, Wakayama, Japan.
4
Second Department of Internal Medicine, Osaka Medical College, Osaka, Japan.
5
Division of Gastroenterology, Department of Internal Medicine, Kobe University Graduate School of Medicine, Hyogo, Japan.
6
Department of Gastroenterology, Bellland General Hospital, Osaka, Japan.
7
Department of Gastroenterology, Oita San-ai Medical Center, Oita, Japan.
8
Department of Gastroenterology, Saku Central Hospital Advanced Care Center, Nagano, Japan.
9
Department of Gastroenterology and Hepatology, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan.
10
Department of Gastroenterology and Neurology, Kagawa University Faculty of Medicine, Kagawa, Japan.
11
Clinical Research Center, Kindai University Hospital, Osaka, Japan.
12
Second Department of Internal Medicine, Wakayama Medical University, Wakayama, Japan.

Abstract

BACKGROUND AND AIM:

Endoscopic ultrasound-guided biliary drainage (EUS-BD) can be carried out by two different approaches: choledochoduodenostomy (CDS) and hepaticogastrostomy (HGS). We compared the efficacy and safety of these approaches in malignant distal biliary obstruction (MDBO) patients using a prospective, randomized clinical trial.

METHODS:

Patients with malignant distal biliary obstruction after failed endoscopic retrograde cholangiopancreatography were randomly selected for either CDS or HGS. The procedures were carried out at nine tertiary centers from September 2013 to March 2016. Primary endpoint was technical success rate, and the noninferiority of HGS to CDS was examined with a one-sided significance level of 5%, where the noninferiority margin was set at 15%. Secondary endpoints were clinical success, adverse events (AE), stent patency, survival time, and overall technical success including alternative EUS-BD procedures.

RESULTS:

Forty-seven patients (HGS, 24; CDS, 23) were enrolled. Technical success rates were 87.5% and 82.6% in the HGS and CDS groups, respectively, where the lower limit of the 90% confidence interval of the risk difference was -12.2% (P = 0.0278). Clinical success rates were 100% and 94.7% in the HGS and CDS groups, respectively (P = 0.475). Overall AE rate, stent patency, and survival time did not differ between the groups. Overall technical success rates were 100% and 95.7% in the HGS and CDS groups, respectively (P = 0.983).

CONCLUSIONS:

This study suggests that HGS is not inferior to CDS in terms of technical success. When one procedure is particularly challenging, readily switching to the other could increase technical success.

KEYWORDS:

EUS-guided biliary drainage; biliary obstruction; choledochoduodenostomy; hepaticogastrostomy; interventional EUS

PMID:
30908711
DOI:
10.1111/den.13406

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