Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07329803

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

ERCP Bile Duct Diseases Biliary Drainage Biliary Stricture Biliary Strictures Caused by Malignant Neoplasms Biliary Tract Diseases Choledocholithiasis Cholelithiasis Common Bile Duct Diseases Digestive System Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Precut Sphincterotomy

Procedure

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.

Double Guidewire Technique

Procedure

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.

Primary outcomes

  1. Safe Success

    Time frame: 30 Days

    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.

Secondary outcomes

  1. Incidence of Post-ERCP Pancreatitis

    Time frame: 30 days

    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.

  2. Severity of Post-ERCP Pancreatitis

    Time frame: 30 days

    Severity of post-ERCP pancreatitis classified as mild, moderate, or severe according to the revised Atlanta classification.

  3. Overall ERCP-Related Adverse Events

    Time frame: 30 days

    Incidence of ERCP-related adverse events, including bleeding, perforation, cholangitis, and post-ERCP pancreatitis, graded according to the ASGE lexicon.

  4. Cannulation Time

    Time frame: During the ERCP procedure

    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.

  5. Total Procedure Time

    Time frame: During the ERCP procedure

    Total ERCP procedure duration, measured from duodenoscope insertion to scope withdrawal.

  6. Need for Rescue Cannulation Technique

    Time frame: During the ERCP procedure

    Proportion of patients requiring crossover to an alternative rescue cannulation technique after failure of the initially assigned technique.

  7. Hyperamylasemia Without Clinical Pancreatitis

    Time frame: At 24 hours after ERCP

    Incidence of asymptomatic hyperamylasemia, defined as serum amylase or lipase ≥3 times the upper limit of normal without clinical features of pancreatitis.

  8. Hospital Length of Stay

    Time frame: Up to 30 days after ERCP

    Duration of hospital stay measured in days from ERCP to hospital discharge

  9. 30-Day All-Cause Readmission

    Time frame: Up to 30 days after ERCP

    Rate of hospital readmission for any cause after ERCP.

Study contacts

Contact information is provided by the study sponsor or research team.

DR SHUJAATH ASIF, MD,DM

CONTACT

[email protected]

9600037286

Sponsors and collaborators

Lead sponsor

Asian Institute of Gastroenterology, India

Other

Registry information

Acronym: PRIDE

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2026
Registry last updated
Jan 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.