NCT03870386

EUS Biliary Drainage vs. ERCP

EUS-guided Biliary Drainage of First Intent With the Lumen Apposing Metal Stent vs. ERCP in the Management of Malignant Distal Biliary Obstruction: a Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 144 (actual)
• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endoscopic ultrasound guided biliary drainage (EUS-BD) is an evolving field that has grown in popularity in the management of malignant biliary obstruction. Although Endoscopic retrograde cholangio-pancreatography (ERCP) with stent insertion has been the mainstay therapy throughout several decades, the transpapillary approach through tumor tissue is associated with significant risk for adverse events such as post-ERCP pancreatitis and stent dysfunction from tumor tissue overgrowth and ingrowth. EUS-BD, through the creation of a choledochoduodenostomy with a stent, has the potential advantage of avoiding the papilla and its associated complications while potentially improving stent patency with lower risks for tumor tissue ingrowth and/or overgrowth.

Conditions

• Biliary Obstruction

Interventions

Type	Name	Description
PROCEDURE	EUS-BD with LAMS	Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy
PROCEDURE	ERCP	Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.

Timeline

• Start date: 2019-03-08
• Primary completion: 2023-05-01
• Completion: 2023-07-01
• First posted: 2019-03-12
• Last updated: 2023-08-14

Locations

11 sites across 2 countries: Canada, France