Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Control… (NCT07329803) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
840 participantsStarted 2026-01-25
Plain-language summary
Endoscopic retrograde cholangiopancreatography (ERCP) is an indispensable therapeutic procedure in the management of a wide spectrum of pancreaticobiliary disorders, including choledocholithiasis, benign and malignant biliary strictures, pancreatic ductal obstructions, and postoperative bile leaks. The procedure has revolutionized the management of these conditions, often obviating the need for surgery.Precut papillotomy and Double Guidewire Technique (DGT) are both salvage techniques used in ERCP when standard biliary cannulation fails.
Precut (Needle-Knife Precut): An endoscopic incision made into the papilla to gain access to the bile duct when conventional methods fail.
Intentional Double Guidewire Technique (DGT): A technique where a guidewire is intentionally placed into the pancreatic duct to act as a "guide" or anchor, straightening the biliary axis and allowing a second guidewire to be inserted into the bile duct.
Who can participate
Age range
18 Years – 75 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:
\- Age \> 18 years.
* Valid indication for ERCP (benign or malignant obstruction).
* Native papilla (no prior sphincterotomy).
* Difficult Biliary Cannulation (DBC) defined by ESGE "5-5-2" criteria:
* \> 5 minutes of cannulation attempts.
* \> 5 contacts with the papilla.
* \> 1 inadvertent pancreatic duct cannulation.
Exclusion Criteria:
* Ampullary mass or tumor preventing standard cannulation view.
* Surgically altered anatomy (e.g., Billroth II, Roux-en-Y).
* Uncorrectable coagulopathy (INR \> 1.5 or Platelets \< 50,000).
* Acute pancreatitis present prior to ERCP.
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.