TY - JOUR
T1 - ELEMENT TRIAL
T2 - 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
AU - Chen, Yen I.
AU - Callichurn, Kashi
AU - Chatterjee, Avijit
AU - Desilets, Etienne
AU - Fergal, Donnellan
AU - Forbes, Nauzer
AU - Gan, Ian
AU - Kenshil, Sana
AU - Khashab, Mouen A.
AU - Kunda, Rastislav
AU - Lam, Eric
AU - May, Gary
AU - Mohamed, Rachid
AU - Mosko, Jeff
AU - Paquin, Sarto C.
AU - Sahai, Anand
AU - Sandha, Gurpal
AU - Teshima, Christopher
AU - Barkun, Alan
AU - Barkun, Jeffrey
AU - Bessissow, Ali
AU - Candido, Kristina
AU - Martel, Myriam
AU - Miller, Corey
AU - Waschke, Kevin
AU - Zogopoulos, George
AU - Wong, Clarence
N1 - Publisher Copyright:
© 2019 The Author(s).
PY - 2019/12/9
Y1 - 2019/12/9
N2 - 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.
AB - 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.
KW - Cholangiopancreatography (ERCP)
KW - Endoscopic retrograde
KW - Endoscopic ultrasound guided-biliary drainage (EUS-BD)
KW - Endoscopy
KW - Malignant distal obstruction
KW - Treatment
KW - Trial
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UR - http://www.scopus.com/inward/citedby.url?scp=85076376569&partnerID=8YFLogxK
U2 - 10.1186/s13063-019-3918-y
DO - 10.1186/s13063-019-3918-y
M3 - Article
C2 - 31818329
AN - SCOPUS:85076376569
SN - 1745-6215
VL - 20
JO - Trials
JF - Trials
IS - 1
M1 - 696
ER -