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, ELEMENT trial and for the Canadian Endoscopic Research Collaborative (CERC), 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, 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.

Keywords: Cholangiopancreatography (ERCP); Endoscopic retrograde; Endoscopic ultrasound guided-biliary drainage (EUS-BD); Endoscopy; Malignant distal obstruction; Treatment; Trial.

Conflict of interest statement

Alan N. Barkun is a consultant for Pendopharm Inc., Boston Scientific Inc., Olympus Canada Inc., and Cook Inc. He has also received “at arms-length” grant funding from both Boston Scientific Inc. and Cook Inc. Yen-I Chen is a consultant for Boston Scientific Inc. Mouen Khashab is a consultant for Boston Scientific, Medtronic, and Olympus. Rastislav Kunda is a consultant for Boston Scientific, Omega, and Olympus. Rachid Mohamed is a consultant for Pentax. Sarto C Paquin is a consultant for Boston Scientific Inc. Anand Sahai is a consultant for Boston Scientific and Pentax. Gurpal Sandha is a consultant for Boston Scientific. The remaining authors disclose no conflicts.

Figures

Fig. 1
Fig. 1
ERCP with traditional metal stent versus EUS-BD with LAMS
Fig. 2
Fig. 2
Enrollment, intervention, and assessment in the ELEMENT trial
Fig. 3
Fig. 3
Flowchart ELEMENT trial

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