Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial (PRIDE)

Asian Institute of Gastroenterology, India

Status: Not yet enrolling

Conditions: ERCP; Biliary Stricture; Choledocholithiasis; Biliary Strictures Caused by Malignant Neoplasms; Biliary Drainage

Treatments: Procedure: Precut Sphincterotomy; Procedure: Double Guidewire Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT07329803

PRIDE

Details and patient eligibility

About

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.

Enrollment: 840 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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840 participants in 2 patient groups

Precut Sphincterotomy Arm

Experimental group

Description:

Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP.

Treatment:

Procedure: Double Guidewire Technique

Double Guidewire Technique Arm

Active Comparator group

Description:

Participants undergo biliary cannulation using the double guidewire technique, with placement of a guidewire in the pancreatic duct followed by attempted biliary cannulation during ERCP.

Treatment:

Procedure: Precut Sphincterotomy