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

被引：62

作者：

Minaga, Kosuke ^{[1
,2
,7
]}

Ogura, Takeshi ^{[1
,3
]}

Shiomi, Hideyuki ^{[1
,6
]}

Imai, Hajime ^{[1
,2
]}

Hoki, Noriyuki ^{[1
,4
]}

Takenaka, Mamoru ^{[1
,2
,6
]}

Nishikiori, Hidefumi ^{[1
,9
]}

Yamashita, Yukitaka ^{[1
,7
]}

Hisa, Takeshi ^{[1
,10
]}

Kato, Hironari ^{[1
,11
]}

Kamada, Hideki ^{[1
,12
]}

Okuda, Atsushi ^{[1
,3
]}

Sagami, Ryota ^{[1
,9
]}

Hashimoto, Hiroaki ^{[1
,4
]}

Higuchi, Kazuhide ^{[1
,3
]}

Chiba, Yasutaka ^{[1
,5
]}

Kudo, Masatoshi ^{[1
,2
]}

Kitano, Masayuki ^{[1
,2
,8
]}

机构：

[1] Kindai Univ, Fac Med, Therapeut Endoscop Ultrasound Grp, Osaka, Japan

[2] Kindai Univ, Fac Med, Dept Gastroenterol & Hepatol, Osaka, Japan

[3] Osaka Med Coll, Dept Internal Med 2, Osaka, Japan

[4] Bellland Gen Hosp, Dept Gastroenterol, Osaka, Japan

[5] Kindai Univ Hosp, Clin Res Ctr, Osaka, Japan

[6] Kobe Univ, Grad Sch Med, Dept Internal Med, Div Gastroenterol, Kobe, Hyogo, Japan

[7] Japanese Red Cross Wakayama Ctr, Dept Gastroenterol, Wakayama, Japan

[8] Wakayama Med Univ, Dept Internal Med 2, 811-1 Kimiidera, Wakayama 6418509, Japan

[9] Oita San Ai Med Ctr, Dept Gastroenterol, Oita, Japan

[10] Saku Cent Hosp, Adv Care Ctr, Dept Gastroenterol, Nagano, Japan

[11] Okayama Univ, Grad Sch Med Dent & Pharmaceut Sci, Dept Gastroenterol & Hepatol, Okayama, Japan

[12] Kagawa Univ, Fac Med, Dept Gastroenterol & Neurol, Takamatsu, Kagawa, Japan

来源：

DIGESTIVE ENDOSCOPY | 2019年 / 31卷 / 05期

基金：

日本学术振兴会;

关键词：

biliary obstruction; choledochoduodenostomy; EUS-guided biliary drainage; hepaticogastrostomy; interventional EUS; FAILED ERCP; DRAINAGE; EXPERIENCE; CANNULATION;

D O I：

10.1111/den.13406

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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.

引用

页码：575 / 582

页数：8

共 24 条

[1] Hepaticogastrostomy or choledochoduodenostomy for distal malignant biliary obstruction after failed ERCP: Is there any difference? [J].