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EUS-Guided Choledocho-duodenostomy Using Lumen Apposing Stent Versus ERCP With Covered Metallic Stents in Patients With Unresectable Malignant Distal Biliary Obstruction: A Multicenter Randomized Controlled Trial (DRA-MBO Trial).
Teoh, Anthony Yuen Bun; Napoleon, Betrand; Kunda, Rastislav; Arcidiacono, Paolo Giorgio; Kongkam, Pradermchai; Larghi, Alberto; Van der Merwe, Schalk; Jacques, Jeremies; Legros, Romain; Thawee, Ratanachu-Ek; Saxena, Payal; Aerts, Maridi; Archibugi, Livia; Chan, Shannon Melissa; Fumex, Fabien; Kaffes, Arthur J; Ma, Mark Tsz Wah; Messaoudi, Nouredin; Rizzatti, Gianenrico; Ng, Kelvin Kwok Chai; Ng, Enders Kwok Wai; Chiu, Philip Wai Yan.
Affiliation
  • Teoh AYB; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China. Electronic address: anthonyteoh@surgery.cuhk.edu.hk.
  • Napoleon B; Hopital Privé Jean Mermoz, Ramsay Santé, Lyon Cedex 08, France.
  • Kunda R; Department of Surgery, Department of Gastroenterology-Hepatology, Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel UZB, Vrije Universiteit Brussel VUB, Brussels, Belgium; Department of Surgical Gastroenterology, Aarhus University Hospital, Aarhus, Denmark.
  • Arcidiacono PG; Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita Salute San Raffaele University, Milan, Italy.
  • Kongkam P; Division of Hospital and Ambulatory Medicine and Division of Gastroenterology, Department of Medicine, Faculty of Medicine, Chulalongkorn University and King Chulalongkorn Memorial Hospital, Thai Red Cross Society, Bangkok, Thailand.
  • Larghi A; Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Van der Merwe S; Department of Gastroenterology and Hepatology, The University of Leuven, Leuven, Belgium.
  • Jacques J; Gastroenterology Department, Dupuytren University Hospital, Limoges, France.
  • Legros R; Gastroenterology Department, Dupuytren University Hospital, Limoges, France.
  • Thawee RE; Department of Surgery, Rajavithi Hospital, Bangkok, Thailand.
  • Saxena P; Department of Gastroenterology, Royal Prince Alfred Hospital, Sidney, Australia.
  • Aerts M; Department of Gastroenterology-Hepatology, Universitair Ziekenhuis Brussel UZB, Vrije Universiteit Brussel VUB, Brussels, Belgium.
  • Archibugi L; Pancreato-Biliary Endoscopy and Endosonography Division, Pancreas Translational & Clinical Research Center, San Raffaele Scientific Institute IRCCS, Vita Salute San Raffaele University, Milan, Italy.
  • Chan SM; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
  • Fumex F; Hopital Privé Jean Mermoz, Ramsay Santé, Lyon Cedex 08, France.
  • Kaffes AJ; Department of Gastroenterology, Royal Prince Alfred Hospital, Sidney, Australia.
  • Ma MTW; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
  • Messaoudi N; Department of Surgery, Universitair Ziekenhuis Brussel UZB, Vrije Universiteit Brussel VUB, Brussels, Belgium.
  • Rizzatti G; Digestive Endoscopy Unit, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy.
  • Ng KKC; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
  • Ng EKW; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
  • Chiu PWY; Department of Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Hong Kong SAR, China.
Gastroenterology ; 165(2): 473-482.e2, 2023 08.
Article in En | MEDLINE | ID: mdl-37121331
BACKGROUND & AIMS: Several studies have compared primary endoscopic ultrasound (EUS)-guided biliary drainage to endoscopic retrograde cholangiopancreatography (ERCP) with insertion of metal stents in unresectable malignant distal biliary obstruction (MDBO) and the results were conflicting. The aim of the current study was to compare the outcomes of the procedures in a large-scale study. METHODS: This was a multicenter international randomized controlled study. Consecutive patients admitted for obstructive jaundice due to unresectable MDBO were recruited. Patients were randomly allocated to receive EUS-guided choledocho-duodenostomy (ECDS) or ERCP for drainage. The primary outcome was the 1-year stent patency rate. Other outcomes included technical success, clinical success, adverse events, time to stent dysfunction, reintervention rates, and overall survival. RESULTS: Between January 2017 and February 2021, 155 patients were recruited (ECDS 79, ERCP 76). There were no significant differences in 1-year stent patency rates (ECDS 91.1% vs ERCP 88.1%, P = .52). The ECDS group had significantly higher technical success (ECDS 96.2% vs ERCP 76.3%, P < .001), whereas clinical success was similar (ECDS 93.7% vs ERCP 90.8%, P = .559). The median (interquartile range) procedural time was significantly shorter in the ECDS group (ECDS 10 [5.75-18] vs ERCP 25 [14-40] minutes, P < .001). The rate of 30-day adverse events (P = 1) and 30-day mortality (P = .53) were similar. CONCLUSION: Both procedures could be options for primary biliary drainage in unresectable MDBO. ECDS was associated with higher technical success and shorter procedural time then ERCP. Primary ECDS may be preferred when difficult ERCPs are anticipated. This study was registered to Clinicaltrials.gov NCT03000855.
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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cholestasis / Neoplasms Type of study: Clinical_trials Limits: Humans Language: En Journal: Gastroenterology Year: 2023 Type: Article

Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Cholestasis / Neoplasms Type of study: Clinical_trials Limits: Humans Language: En Journal: Gastroenterology Year: 2023 Type: Article