Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation (NCT02197338) | Clinical Trial Compass
CompletedNot Applicable
Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation
United States498 participantsStarted 2016-04
Plain-language summary
1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.
2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP).
3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages.
4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care.
5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation
6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.
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
. Undergoing ERCP at LAC+USC Medical Centers for standard indications including bile duct stones, bile leak, and biliary obstruction will be included.
Exclusion criteria
. Prior ERCP with sphincterotomy
. Prior ERCP with failed bile duct cannulation
. Pregnant, imprisoned, under age 18, unable to give informed consent
. Prior biliary diversion surgery will be excluded
. Those who require ERCP only for pancreatic duct indications will also be excluded as bile duct cannulation is not clinically necessary in this group
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.