Yen-I Chen1, Kashi Callichurn2, Avijit Chatterjee3, Etienne Desilets4, Donnellan Fergal5, Nauzer Forbes6, Ian Gan5, Sana Kenshil3, Mouen A Khashab7, Rastislav Kunda8, Eric Lam9, Gary May10, Rachid Mohamed6, Jeff Mosko10, Sarto C Paquin2, Anand Sahai2, Gurpal Sandha11, Christopher Teshima10, Alan Barkun12, Jeffrey Barkun13, Ali Bessissow14, Kristina Candido12, Myriam Martel12, Corey Miller12, Kevin Waschke12, George Zogopoulos13, Clarence Wong15. 1. Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada. yen-i.chen@mcgill.ca. 2. Division of Gastroenterology, Centre Hospitalier de l'Université de Montréal, Montreal, QC, Canada. 3. Division of Gastroenterology and Hepatology, Ottawa Hospital, University of Ottawa, Ottawa, ON, Canada. 4. Division of Gastroenterology, Hôpital Charles-Le Moyne, University of Sherbrooke, Greenfield Park, QC, Canada. 5. Division of Gastroenterology and Hepatology, Vancouver General Hospital, University of British Columbia, Vancouver, BC, Canada. 6. Division of Gastroenterology and Hepatology, University of Calgary, Calgary, AB, Canada. 7. Division of Gastroenterology and Hepatology, Johns Hopkins Hospital, Baltimore, MD, USA. 8. Department of Surgery, Department of Gastroenterology and Hepatology, Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel, Brussels, Belgium. 9. Division of Gastroenterology and Hepatology, St-Paul's Hospital, University of British Columbia, Vancouver, BC, Canada. 10. Division of Gastroenterology and Hepatology, St-Michael's Hospital, University of Toronto, Toronto, ON, Canada. 11. Division of Gastroenterology and Hepatology, University of Alberta Hospital, University of Alberta, Edmonton, AB, Canada. 12. Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University, Montreal, QC, Canada. 13. Department of Surgery, McGill University Health Centre, McGill University, Montreal, QC, Canada. 14. Department of Radiology, McGill University Health Centre, McGill University, Montreal, QC, Canada. 15. Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta, Edmonton, AB, Canada.
Abstract
BACKGROUND & AIMS:Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. METHODS: The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. TRIAL REGISTRATION: Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
RCT Entities:
BACKGROUND & AIMS: Endoscopic ultrasound guided-biliary drainage (EUS-BD) is a promising alternative to endoscopic retrograde cholangiopancreatography (ERCP); however, its growth has been limited by a lack of multicenter randomized controlled trials (RCT) and dedicated devices. A dedicated EUS-BD lumen- apposing metal stent (LAMS) has recently been developed with the potential to greatly facilitate the technique and safety of the procedure. We aim to compare a first intent approach with EUS-guided choledochoduodenostomy with a dedicated biliary LAMS vs. standard ERCP in the management of malignant distal biliary obstruction. METHODS: The ELEMENT trial is a multicenter single-blinded RCT involving 130 patients in nine Canadian centers. Patients with unresectable, locally advanced, or borderline resectable malignant distal biliary obstruction meeting the inclusion and exclusion criteria will be randomized to EUS-choledochoduodenostomy using a LAMS or ERCP with traditional metal stent insertion in a 1:1 proportion in blocks of four. Patients with hilar obstruction, resectable cancer, or benign disease are excluded. The primary endpoint is the rate of stent dysfunction needing re-intervention. Secondary outcomes include technical and clinical success, interruptions in chemotherapy, rate of surgical resection, time to stent dysfunction, and adverse events. DISCUSSION: The ELEMENT trial is designed to assess whether EUS-guided choledochoduodenostomy using a dedicated LAMS is superior to conventional ERCP as a first-line endoscopic drainage approach in malignant distal biliary obstruction, which is an important and timely question that has not been addressed using an RCT study design. TRIAL REGISTRATION: Registry name: ClinicalTrials.gov. Registration number: NCT03870386. Date of registration: 03/12/2019.
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