EUS Biliary Drainage vs. ERCP (NCT03870386) | Clinical Trial Compass
CompletedNot Applicable
EUS Biliary Drainage vs. ERCP
Canada, France144 participantsStarted 2019-03-08
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Radiological diagnosis (with or without pathological diagnosis) of borderline resectable, locally advanced, or unresectable malignant distal biliary obstruction at least 2 cm distal to the hilum. Resectability based on tumor staging on axial imaging and surgeon evaluation.
* Elevated liver tests with serum bilirubin at least 3 times above the upper limit of normal (18.9 umol/L)
* Dilated extra-hepatic bile duct measuring at least 1.2 cm on axial imaging or US
* Confirmation of bile duct accessibility and size of at least 1.2 cm on endoscopic ultrasound
* Karnofsky index \> 30%
* ASA score \<IV
* Provision of informed consent
Exclusion Criteria:
* Hilar obstruction (biliary obstruction \< 2 cm from the hilum)
* Uncorrectable coagulopathy and/or thrombocytopenia
* Age \< 18
* Liver metastasis involving \> 30% of the liver volume
* Liver cirrhosis with portal hypertension or ascites
* Prior biliary sphincterotomy or stent placement
* Surgically altered anatomy
* Common bile duct measuring less than 1.2 cm will be excluded
* Patient with clinical and radiological evidence of gastric outlet obstruction
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of re-intervention
Timeframe: 1 year
Trial details
NCT IDNCT03870386
SponsorMcGill University Health Centre/Research Institute of the McGill University Health Centre