Tae Hoon Lee1, Jun-Ho Choi2, Do Hyun Park3, Tae Jun Song4, Dong Uk Kim5, Woo Hyun Paik6, Young Hwangbo7, Sang Soo Lee4, Dong Wan Seo4, Sung Koo Lee4, Myung-Hwan Kim4. 1. Department of Internal Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea. 2. Department of Internal Medicine, Dankook University Hospital, Dankook University College of Medicine, Cheonan, South Korea. 3. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. Electronic address: dhpark@amc.seoul.kr. 4. Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, South Korea. 5. Department of Internal Medicine, Pusan National University Hospital, Pusan National University School of Medicine, Pusan, South Korea. 6. Department of Internal Medicine, Inje University Ilsan Paik Hospital, Inje University School of Medicine, Ilsan, South Korea. 7. Division of Preventive Medicine, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, South Korea.
Abstract
BACKGROUND & AIMS: 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. METHODS: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). RESULTS: 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. CONCLUSIONS: EUS-BD and PTBD had similar levels of efficacy in patients with unresectable malignant distal biliary obstruction and inaccessible papilla based onrates 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.
RCT Entities:
BACKGROUND & AIMS: 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. METHODS: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). RESULTS: 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. CONCLUSIONS: 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: Abdul H El Chafic; Janak N Shah; Chris Hamerski; Kenneth F Binmoeller; Shayan Irani; Theodore W James; Todd H Baron; Jose Nieto; Ricardo V Romero; John A Evans; Michel Kahaleh Journal: Dig Dis Sci Date: 2019-06-07 Impact factor: 3.199
Authors: Francesco De Cobelli; Paolo Marra; Pietro Diana; Giorgio Brembilla; Massimo Venturini Journal: Endosc Ultrasound Date: 2017-12 Impact factor: 5.628