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

Study acronym: PRIDE
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Interventions: Early Precut Sphincterotomy (Needle-Knife (Procedure), Intentional Double Guidewire (DGW) (Procedure) to Double Guidewire Technique (Procedure), Precut Sphincterotomy (Procedure)
    • Study title revised
    v2
  2. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07329803
Lead Sponsor Asian Institute of Gastroenterology, India
Conditions
(from sponsor)
ERCP, Choledocholithiasis, Biliary Drainage, Biliary Strictures Caused by Malignant Neoplasms, Biliary Stricture
Related terms Choledocholithiasis
Enrollment 840 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov