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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Choledocholithiasis; Biliary Stricture; ERCP; Biliary Strictures Caused by Malignant Neoplasms; Biliary Drainage
• Intervention / Treatment: Procedure: Double Guidewire Technique; Procedure: Precut Sphincterotomy

• Study Type: Interventional
• Enrollment (Estimated): 840
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: DR SHUJAATH ASIF, MD,DM; Phone Number: 9600037286; Email: Asif.shujaath@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Precut Sphincterotomy Arm; Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP.	Procedure: Double Guidewire Technique; The double guidewire technique is an endoscopic rescue cannulation method in which a guidewire is placed into the pancreatic duct to stabilize the papilla, followed by attempted biliary cannulation alongside the pancreatic duct guidewire during ERCP.
Active Comparator: Double Guidewire Technique Arm; 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.	Procedure: Precut Sphincterotomy; Precut sphincterotomy is an endoscopic rescue cannulation technique in which a needle-knife or similar cutting instrument is used to incise the papillary or periampullary tissue to facilitate access to the bile duct during ERCP.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safe Success	SUCCESS: Deep cannulation of the Common Bile Duct (CBD) achieved using the randomized technique within 15 minutes.; AND ABSENCE OF Post ERCP adverse events. Post ERCP adverse events include Post ERCP Pancreatitis, Hemorrhage, cholangitis and perforation.	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Post-ERCP Pancreatitis	Incidence of post-ERCP pancreatitis, defined as new or worsened abdominal pain with serum amylase or lipase ≥3 times the upper limit of normal at ≥24 hours after ERCP, requiring hospitalization or prolongation of planned admission.	30 days
Severity of Post-ERCP Pancreatitis	Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification.	30 days
Overall ERCP-Related Adverse Events	Incidence of ERCP-related adverse events, including bleeding, perforation, cholangitis, and post-ERCP pancreatitis, graded according to the ASGE lexicon.	30 days
Cannulation Time	Time required to achieve deep biliary cannulation, measured from insertion of the duodenoscope into the second part of the duodenum to successful deep bile duct cannulation.	During the ERCP procedure
Total Procedure Time	Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal.	During the ERCP procedure
Need for Rescue Cannulation Technique	Proportion of patients requiring crossover to an alternative rescue cannulation technique after failure of the initially assigned technique.	During the ERCP procedure
Hyperamylasemia Without Clinical Pancreatitis	Incidence of asymptomatic hyperamylasemia, defined as serum amylase or lipase ≥3 times the upper limit of normal without clinical features of pancreatitis.	At 24 hours after ERCP
Hospital Length of Stay	Duration of hospital stay measured in days from ERCP to hospital discharge	Up to 30 days after ERCP
30-Day All-Cause Readmission	Rate of hospital readmission for any cause after ERCP.	Up to 30 days after ERCP

Collaborators and Investigators

• Sponsor: Asian Institute of Gastroenterology, India
• Investigators: Principal Investigator: DR SHUJAATH ASIF, MD,DM, Asian Institute Of Gastroenterology Private Limited

Study record dates

Study Major Dates

• Study Start (Estimated): January 25, 2026
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 26, 2025
• First Submitted That Met QC Criteria: December 27, 2025
• First Posted (Estimated): January 9, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 9, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Selective CBD cannulation; Post ERCP Pancreatitis; Precut Sphincterotomy; Double Guidewire Technique
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Cholelithiasis; Common Bile Duct Diseases; Choledocholithiasis
• Other Study ID Numbers: PRIDE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No