Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
Starting soon · Not applicable
Conditions studied: ERCP, Choledocholithiasis, Biliary Drainage, Biliary Strictures Caused by Malignant Neoplasms, Biliary Stricture
In brief
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.
Key facts
- Study ID
- NCT07329803
- Run by
- Asian Institute of Gastroenterology, India
- People needed
- 840
- Starts
- 2026-01-25
- Expected to finish
- 2027-02-28
- Last updated by the study team
- 2026-01-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Full record on ClinicalTrials.gov
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