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EUS-BD with LAMS for Biliary Obstruction
N/A
Waitlist Available
Led By Yen-I Chen, MD
Research Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial is testing whether EUS-BD is better than ERCP for biliary drainage in people with malignant biliary obstruction.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Rate of re-intervention
Secondary outcome measures
Clinical success
Early adverse events
Stent patency
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: EUS-BD with LAMSExperimental Treatment1 Intervention
A curvilinear endoscope is inserted orally and advanced to the duodenal bulb. Biliary accessibility is confirmed via EUS and with Doppler to rule out any intervening vessels. For common bile ducts < 15 mm in diameter, the biliary access is established via needle puncture with a 19-gauge needle followed by advancement of a 0.035 or 0.025 inch guidewire. A LAMS (AxiosTM) will then be inserted with cautery assistance without tract dilation and deployed. For common bile ducts > 15 mm, the need for initial needle puncture and wire insertion is at the discretion of the endoscopist. A cholangiogram is then performed through the LAMS with contrast injection. The choice of stent size will be at the discretion of the endoscopist (8 x 8 mm or 6 x 8 mm).
Group II: Traditional transpapillary metal stent via ERCPActive Control1 Intervention
A duodenoscope is advanced orally to the papilla. The bile duct is then cannulated with a sphincterotome using the guidewire-assisted technique. A cholangiogram is then performed followed by insertion of a self-expanding metal biliary stent. The performance of a biliary sphincterotomy prior to stent insertion and the choice of stent size (10x 40 mm, 10 x 60 mm, 10x 80 mm) will be at the discretion of the endoscopist.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EUS-BD with LAMS
2019
N/A
~150
Find a Location
Who is running the clinical trial?
McGill University Health Centre/Research Institute of the McGill University Health CentreLead Sponsor
446 Previous Clinical Trials
159,582 Total Patients Enrolled
Yen-I Chen, MDPrincipal InvestigatorMcGill University Health Centre/Research Institute of the McGill University Health Centre
1 Previous Clinical Trials
235 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there openings for participants to join this clinical experiment?
"Clinicaltrials.gov shows that this trial, initiated on March 8th 2019 and most recently modified on the 20th of March 2022 is not currently seeking applicants. Nevertheless, there are still 5 other trials in need of participants."
Answered by AI
What is the aggregate count of healthcare facilities hosting this experiment?
"This trial is running in multiple Canadian cities, including Toronto, Montréal, Alberta, and Edmonton. Additionally, there are 10 more sites with active recruitment as part of this study."
Answered by AI
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