ELEMENT TRIAL: study protocol for a randomized controlled trial on endoscopic ultrasound-guided biliary drainage of first intent with a lumen-apposing metal stent vs. endoscopic retrograde cholangio-pancreatography in the management of malignant distal biliary obstruction
Yen-I Chen,
Kashi Callichurn,
Avijit Chatterjee,
Etienne Desilets,
Donnellan Fergal,
Nauzer Forbes,
Ian Gan,
Sana Kenshil,
Mouen A. Khashab,
Rastislav Kunda,
Eric Lam,
Gary May,
Rachid Mohamed,
Jeff Mosko,
Sarto C. Paquin,
Anand Sahai,
Gurpal Sandha,
Christopher Teshima,
Alan Barkun,
Jeffrey Barkun,
Ali Bessissow,
Kristina Candido,
Myriam Martel,
Corey Miller,
Kevin Waschke,
George Zogopoulos,
Clarence Wong,
for the ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC)
Affiliations
Yen-I Chen
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
Kashi Callichurn
Division of Gastroenterology, Centre Hospitalier de l’Université de Montréal
Avijit Chatterjee
Division of Gastroenterology and Hepatology, Ottawa Hospital, University of Ottawa
Etienne Desilets
Division of Gastroenterology, Hôpital Charles-Le Moyne, University of Sherbrooke
Donnellan Fergal
Division of Gastroenterology and Hepatology, Vancouver General Hospital, University of British Columbia
Nauzer Forbes
Division of Gastroenterology and Hepatology, University of Calgary
Ian Gan
Division of Gastroenterology and Hepatology, Vancouver General Hospital, University of British Columbia
Sana Kenshil
Division of Gastroenterology and Hepatology, Ottawa Hospital, University of Ottawa
Mouen A. Khashab
Division of Gastroenterology and Hepatology, Johns Hopkins Hospital
Rastislav Kunda
Department of Surgery, Department of Gastroenterology and Hepatology, Department of Advanced Interventional Endoscopy, Universitair Ziekenhuis Brussel, Vrije Universiteit Brussel
Eric Lam
Division of Gastroenterology and Hepatology, St-Paul’s Hospital, University of British Columbia
Gary May
Division of Gastroenterology and Hepatology, St-Michael’s Hospital, University of Toronto
Rachid Mohamed
Division of Gastroenterology and Hepatology, University of Calgary
Jeff Mosko
Division of Gastroenterology and Hepatology, St-Michael’s Hospital, University of Toronto
Sarto C. Paquin
Division of Gastroenterology, Centre Hospitalier de l’Université de Montréal
Anand Sahai
Division of Gastroenterology, Centre Hospitalier de l’Université de Montréal
Gurpal Sandha
Division of Gastroenterology and Hepatology, University of Alberta Hospital, University of Alberta
Christopher Teshima
Division of Gastroenterology and Hepatology, St-Michael’s Hospital, University of Toronto
Alan Barkun
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
Jeffrey Barkun
Department of Surgery, McGill University Health Centre, McGill University
Ali Bessissow
Department of Radiology, McGill University Health Centre, McGill University
Kristina Candido
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
Myriam Martel
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
Corey Miller
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
Kevin Waschke
Division of Gastroenterology and Hepatology, McGill University Health Centre, McGill University
George Zogopoulos
Department of Surgery, McGill University Health Centre, McGill University
Clarence Wong
Division of Gastroenterology and Hepatology, Royal Alexandra Hospital, University of Alberta
for the ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC)
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.
