MedTrace Logo

EUS Biliary Drainage vs. ERCP

NCT03870386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 144

Last updated 2023-08-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

    lead OTHER

Principal Investigators

  • Yen-I Chen, MD · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2023-05-01
Completion
2023-07-01

Countries

  • Canada
  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03870386 on ClinicalTrials.gov