Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction

Multicenter, randomized, clinical trial

Kosuke Minaga, Takeshi Ogura, Hideyuki Shiomi, Hajime Imai, Noriyuki Hoki, Mamoru Takenaka, Hidefumi Nishikiori, Yukitaka Yamashita, Takeshi Hisa, Hironari Katou, Hideki Kamada, Atsushi Okuda, Ryota Sagami, Hiroaki Hashimoto, Kazuhide Higuchi, Yasutaka Chiba, Masatoshi Kudo, Masayuki Kitano

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalDigestive Endoscopy
DOIs
Publication statusPublished - Jan 1 2019

Fingerprint

Choledochostomy
Randomized Controlled Trials
Safety
Stents
Drainage
Survival
Endoscopic Retrograde Cholangiopancreatography
Confidence Intervals

Keywords

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

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Gastroenterology

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Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction : Multicenter, randomized, clinical trial. / Minaga, Kosuke; Ogura, Takeshi; Shiomi, Hideyuki; Imai, Hajime; Hoki, Noriyuki; Takenaka, Mamoru; Nishikiori, Hidefumi; Yamashita, Yukitaka; Hisa, Takeshi; Katou, Hironari; Kamada, Hideki; Okuda, Atsushi; Sagami, Ryota; Hashimoto, Hiroaki; Higuchi, Kazuhide; Chiba, Yasutaka; Kudo, Masatoshi; Kitano, Masayuki.

In: Digestive Endoscopy, 01.01.2019.

Research output: Contribution to journalArticle

Minaga, K, Ogura, T, Shiomi, H, Imai, H, Hoki, N, Takenaka, M, Nishikiori, H, Yamashita, Y, Hisa, T, Katou, H, Kamada, H, Okuda, A, Sagami, R, Hashimoto, H, Higuchi, K, Chiba, Y, Kudo, M & Kitano, M 2019, 'Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction: Multicenter, randomized, clinical trial', Digestive Endoscopy. https://doi.org/10.1111/den.13406
Minaga, Kosuke ; Ogura, Takeshi ; Shiomi, Hideyuki ; Imai, Hajime ; Hoki, Noriyuki ; Takenaka, Mamoru ; Nishikiori, Hidefumi ; Yamashita, Yukitaka ; Hisa, Takeshi ; Katou, Hironari ; Kamada, Hideki ; Okuda, Atsushi ; Sagami, Ryota ; Hashimoto, Hiroaki ; Higuchi, Kazuhide ; Chiba, Yasutaka ; Kudo, Masatoshi ; Kitano, Masayuki. / Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction : Multicenter, randomized, clinical trial. In: Digestive Endoscopy. 2019.
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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.",
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T1 - Comparison of the efficacy and safety of endoscopic ultrasound-guided choledochoduodenostomy and hepaticogastrostomy for malignant distal biliary obstruction

T2 - Multicenter, randomized, clinical trial

AU - Minaga, Kosuke

AU - Ogura, Takeshi

AU - Shiomi, Hideyuki

AU - Imai, Hajime

AU - Hoki, Noriyuki

AU - Takenaka, Mamoru

AU - Nishikiori, Hidefumi

AU - Yamashita, Yukitaka

AU - Hisa, Takeshi

AU - Katou, Hironari

AU - Kamada, Hideki

AU - Okuda, Atsushi

AU - Sagami, Ryota

AU - Hashimoto, Hiroaki

AU - Higuchi, Kazuhide

AU - Chiba, Yasutaka

AU - Kudo, Masatoshi

AU - Kitano, Masayuki

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

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KW - biliary obstruction

KW - choledochoduodenostomy

KW - EUS-guided biliary drainage

KW - hepaticogastrostomy

KW - interventional EUS

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