Woo Hyun Paik1,1, Tae Hoon Lee1, Do Hyun Park1, Jun-Ho Choi1, Seon-Ok Kim1, Sunguk Jang1, Dong Uk Kim1, Ju Hyun Shim1, Tae Jun Song1, Sang Soo Lee1, Dong-Wan Seo1, Sung Koo Lee1, Myung-Hwan Kim1. 1. Department of Internal Medicine, Seoul National University Hospital, Seoul, South Korea. Ilsan Paik Hospital, Goyang, South Korea. Department of Internal Medicine, Cheonan Hospital, Soonchunhyang University College of Medicine, Cheonan, South Korea. Department of Internal Medicine, Division of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Department of Internal Medicine, Dankook University College of Medicine, Dankook University Hospital, Cheonan, South Korea. Department of Clinical Epidemiology and Biostatistics, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea. Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH, USA. Department of Internal Medicine, Pusan National University School of Medicine, Pusan National University Hospital, Pusan, South Korea. These authors contributed equally to this article as first authors: Woo Hyun Paik, Tae Hoon Lee.
Abstract
OBJECTIVES: The goal of the study was to determine whether endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is comparable to conventional transpapillary stenting with endoscopic retrograde cholangiopancreatography (ERCP) in palliation of malignant distal biliary obstruction. Although ERCP for the palliation of malignant biliary obstruction is the standard of care, post-procedure pancreatitis and stent dysfunctions are not uncommon. While EUS-BD has garnered interest as a viable alternative when ERCP is impossible, its role as a primary palliation of malignant distal biliary obstruction is yet to be proven. METHODS: We performed random allocation to EUS-BD or ERCP in 125 patients with unresectable malignant distal biliary obstruction at four tertiary academic referral centers in South Korea. RESULTS:Technical success rates were 93.8% (60/64) for EUS-BD and 90.2% (55/61) for ERCP (difference 3.6%, 95% 1-sided confidence interval lower limit -4.4%, P = 0.003 for noninferiority margin of 10%). Clinical success rates were 90.0% (54/60) in EUS-BD and 94.5% (52/55) in ERCP (P = 0.49). Lower rates of overall adverse events (6.3% vs 19.7%, P = 0.03) including post-procedure pancreatitis (0 vs 14.8%), reintervention (15.6% vs 42.6%), and higher rate of stent patency (85.1% vs 48.9%) were observed with EUS-BD. EUS-BD was also associated with more preserved quality of life (QOL) than transpapillary stenting after 12 weeks of the procedure. CONCLUSIONS: This study demonstrated comparable technical and clinical success rates between EUS-BD and ERCP in relief malignant distal biliary obstruction. Substantially longer duration of patency coupled with lower rates of adverse events and reintervention, and more preserved QOL were observed with EUS-BD (cris.nih.go.kr, Identifier: KCT0001396, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=9716<ype=&rtype= ).
RCT Entities:
OBJECTIVES: The goal of the study was to determine whether endoscopic ultrasound (EUS)-guided biliary drainage (EUS-BD) is comparable to conventional transpapillary stenting with endoscopic retrograde cholangiopancreatography (ERCP) in palliation of malignant distal biliary obstruction. Although ERCP for the palliation of malignant biliary obstruction is the standard of care, post-procedure pancreatitis and stent dysfunctions are not uncommon. While EUS-BD has garnered interest as a viable alternative when ERCP is impossible, its role as a primary palliation of malignant distal biliary obstruction is yet to be proven. METHODS: We performed random allocation to EUS-BD or ERCP in 125 patients with unresectable malignant distal biliary obstruction at four tertiary academic referral centers in South Korea. RESULTS: Technical success rates were 93.8% (60/64) for EUS-BD and 90.2% (55/61) for ERCP (difference 3.6%, 95% 1-sided confidence interval lower limit -4.4%, P = 0.003 for noninferiority margin of 10%). Clinical success rates were 90.0% (54/60) in EUS-BD and 94.5% (52/55) in ERCP (P = 0.49). Lower rates of overall adverse events (6.3% vs 19.7%, P = 0.03) including post-procedure pancreatitis (0 vs 14.8%), reintervention (15.6% vs 42.6%), and higher rate of stent patency (85.1% vs 48.9%) were observed with EUS-BD. EUS-BD was also associated with more preserved quality of life (QOL) than transpapillary stenting after 12 weeks of the procedure. CONCLUSIONS: This study demonstrated comparable technical and clinical success rates between EUS-BD and ERCP in relief malignant distal biliary obstruction. Substantially longer duration of patency coupled with lower rates of adverse events and reintervention, and more preserved QOL were observed with EUS-BD (cris.nih.go.kr, Identifier: KCT0001396, https://cris.nih.go.kr/cris/search/search_result_st01_en.jsp?seq=9716<ype=&rtype= ).
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: Marina de Benito Sanz; Rodrigo Nájera-Muñoz; Carlos de la Serna-Higuera; Esteban Fuentes-Valenzuela; Ignacio Fanjul; Carlos Chavarría; Francisco Javier García-Alonso; Ramón Sanchez-Ocana; Ana Yaiza Carbajo; Sergio Bazaga; Manuel Perez-Miranda Journal: Surg Endosc Date: 2020-11-30 Impact factor: 4.584