title: Similar Efficacies of Endoscopic Ultrasound-guided Transmural and Percutaneous Drainage for Malignant Distal Biliary Obstruction.
abstract: Although percutaneous transhepatic biliary drainage (PTBD) is the standard method for draining a malignant biliary obstruction after failed endoscopic retrograde cholangiopancreatographies (ERCPs), use of endoscopic ultrasound-guided transmural biliary drainage (EUS-BD) is increasing. We performed a multicenter, open-label, randomized trial to compare EUS-BD vs PTBD for malignant distal biliary obstruction after a failed ERCP.
  
  
  
  Patients with unresectable malignant distal biliary obstructions and failed primary ERCP, caused by inaccessible papilla, were assigned to groups that underwent EUS-BD with an all-in-one device for direct deployment of a partially covered metal stent (without further fistula tract dilation, n = 34) or PTBD (n = 32). The procedures were performed at 4 tertiary academic referral centers in South Korea from October 2014 through March 2015; patients were followed up through June 2015. The primary end point was technical success, which was calculated using a noninferiority model. Secondary end points were functional success, procedure-related adverse events, rate of unscheduled re-intervention, and quality of life (QOL).
  
  
  
  The rates of primary technical success were 94.1% (32 of 34) in the EUS-BD group and 96.9% (31 of 32) in the PTBD group (1-sided 97.5% confidence interval lower limit, -12.7%; P = .008 for a noninferiority margin of 15%). The rates of functional success were 87.5% (28 of 32) in the EUS-BD group and 87.1% (27 of 31) in the PTBD group (P = 1.00). The proportions of procedure-related adverse events were 8.8% in the EUS-BD group vs 31.2% in the PTBD group (P = .022); the mean frequency of unscheduled re-intervention was 0.34 in the EUS-BD group vs 0.93 in the PTBD group (P = .02). The QOL was similar between groups.
  
  
  
  EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla based on rates of technical and functional success and QOL. However, EUS-BD produced fewer procedure-related adverse events and unscheduled re-interventions. Clinical trial registration no: cris.nih.go.kr/KCT0001370.
authors.affiliation: Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.
authors.forename: Tae Hoon
authors.initials: TH
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea.
authors.forename: Jun-Ho
authors.initials: JH
authors.lastname: Choi
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: dhpark@amc.seoul.kr.
authors.forename: Do Hyun
authors.initials: do H
authors.lastname: Park
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Tae Jun
authors.initials: TJ
authors.lastname: Song
authors.affiliation: Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Pusan, South Korea.
authors.forename: Dong Uk
authors.initials: DU
authors.lastname: Kim
authors.affiliation: Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University School of Medicine, Ilsan, South Korea.
authors.forename: Woo Hyun
authors.initials: WH
authors.lastname: Paik
authors.affiliation: Division of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.
authors.forename: Young
authors.initials: Y
authors.lastname: Hwangbo
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Sang Soo
authors.initials: SS
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Dong Wan
authors.initials: DW
authors.lastname: Seo
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Sung Koo
authors.initials: SK
authors.lastname: Lee
authors.affiliation: Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea.
authors.forename: Myung-Hwan
authors.initials: MH
authors.lastname: Kim
mesh_terms: D000046:Academic Medical Centers; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001661:Biliary Tract Neoplasms / Q000150:complications*; D001651:Cholestasis, Extrahepatic / Q000601:surgery*; D004322:Drainage / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D011788:Quality of Life / Q000523:psychology; D056910:Republic of Korea; D062606:Tertiary Care Centers; D016896:Treatment Outcome
keywords: Biliary Tract Obstruction; ERCP; Endoscopic Ultrasound; Percutaneous Transhepatic Biliary Drainage