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)

• Published in: Gastroenterology (New York, N.Y. 1943) Vol. 165; no. 2; pp. 473 - 482.e2
• Main Authors: 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
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.08.2023; Elsevier
• Subjects: Cholangiopancreatography, Endoscopic Retrograde - adverse effects; Cholangiopancreatography, Endoscopic Retrograde - methods; Cholestasis - diagnostic imaging; Cholestasis - etiology; Cholestasis - surgery; Common Bile Duct; Drainage - adverse effects; Drainage - methods; Duodenostomy; Endosonography - methods; ERCP; EUS-guided Choledocho-duodenostomy; Human health and pathology; Humans; Hépatology and Gastroenterology; LAMS; Life Sciences; Lumen Apposing Stent; Malignant Distal Biliary Obstruction; Neoplasms - etiology; Self-expanding Metal Stent; Stents - adverse effects; Ultrasonography, Interventional - methods; MDBO; PTBD; CBD; Malignant Distal Biliary Obstruction; ITT; CSEMS; ECDS; EUS-guided Choledocho-duodenostomy; LAMS; ERCP; Self-expanding Metal Stent; Lumen Apposing Stent; EUS-BD; SEMS
• ISSN: 0016-5085; 1528-0012
• DOI: 10.1053/j.gastro.2023.04.016

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. 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. 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. 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. Endosonography-guided choledocho-duodenostomy and endoscopic retrograde cholangiopancreatoscopy could be options for primary biliary drainage in unresectable malignant biliary obstructions. Primary choledocho-duodenostomy may be preferred when difficult endoscopic retrograde cholangiopancreatoscopies are anticipated.