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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

840 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-25

Study Completion Date

2027-02-28

Brief Summary

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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.

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Detailed Description

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Conditions

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ERCP Choledocholithiasis Biliary Drainage Biliary Strictures Caused by Malignant Neoplasms Biliary Stricture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Precut Sphincterotomy Arm

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

Group Type EXPERIMENTAL

Double Guidewire Technique

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Precut Sphincterotomy

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No