Kosuke Minaga1,2,3, Takeshi Ogura1,4, Hideyuki Shiomi1,5, Hajime Imai1,2, Noriyuki Hoki1,6, Mamoru Takenaka1,2,5, Hidefumi Nishikiori1,7, Yukitaka Yamashita1,3, Takeshi Hisa1,8, Hironari Kato1,9, Hideki Kamada1,10, Atsushi Okuda1,4, Ryota Sagami1,7, Hiroaki Hashimoto1,6, Kazuhide Higuchi1,4, Yasutaka Chiba1,11, Masatoshi Kudo1,2, Masayuki Kitano1,2,12. 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 failedendoscopic 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.
RCT Entities:
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.