Clinical trial · Interventional
Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Drainage | — | UNRESOLVED | — |
| Biliary Stricture | — | UNRESOLVED | — |
| Biliary Strictures Caused by Malignant Neoplasms | — | UNRESOLVED | — |
| Choledocholithiasis | — | UNRESOLVED | — |
| ERCP | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Double Guidewire Technique | Procedure | — | UNRESOLVED |
| Precut Sphincterotomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Precut Sphincterotomy Arm
- description
- Participants undergo biliary cannulation using precut sphincterotomy as the initial rescue cannulation technique during ERCP.
- interventionNames
- Procedure: Double Guidewire Technique
- type
- ACTIVE_COMPARATOR
- label
- Double Guidewire Technique Arm
- description
- 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.
- interventionNames
- Procedure: Precut Sphincterotomy
Primary outcomes (1)
- measure
- Safe Success
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available