NCT07329803

Brief Summary

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 Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
840

participants targeted

Target at P75+ for not_applicable

Timeline
10mo left

Started Jan 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Feb 2027

First Submitted

Initial submission to the registry

December 26, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 9, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

January 25, 2026

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.1 years

First QC Date

December 26, 2025

Last Update Submit

January 9, 2026

Conditions

ERCPCholedocholithiasisBiliary DrainageBiliary Strictures Caused by Malignant NeoplasmsBiliary Stricture

Keywords

Selective CBD cannulationPost ERCP PancreatitisPrecut SphincterotomyDouble Guidewire Technique

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Incidence of Post-ERCP Pancreatitis

    30 days

  • Severity of Post-ERCP Pancreatitis

    30 days

  • Overall ERCP-Related Adverse Events

    30 days

  • Cannulation Time

    During the ERCP procedure

  • Total Procedure Time

    During the ERCP procedure

  • +4 more secondary outcomes

Study Arms (2)

Precut Sphincterotomy Arm

EXPERIMENTAL

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

Procedure: Double Guidewire Technique

Double Guidewire Technique Arm

ACTIVE COMPARATOR

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

Interventions

Precut SphincterotomyPROCEDURE

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 Arm
Double Guidewire TechniquePROCEDURE

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.

Precut Sphincterotomy Arm

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Choledocholithiasis

Condition Hierarchy (Ancestors)

Common Bile Duct DiseasesBile Duct DiseasesBiliary Tract DiseasesDigestive System DiseasesCholelithiasis

Study Officials

  • DR SHUJAATH ASIF, MD,DM

    Asian Institute Of Gastroenterology Private Limited

    PRINCIPAL INVESTIGATOR

Central Study Contacts

DR SHUJAATH ASIF, MD,DM

CONTACT

9600037286Asif.shujaath@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterology

Study Record Dates

First Submitted

December 26, 2025

First Posted

January 9, 2026

Study Start

January 25, 2026

Primary Completion (Estimated)

February 28, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

January 12, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share