Pre-cut Versus Intentional Double Guidewire for ERCP Cannulation: Prospective, Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Precut Sphincterotomy, Double Guidewire Technique.
- Who it may be relevant to
- Registry conditions: ERCP, Choledocholithiasis, Biliary Drainage, Biliary Strictures Caused by Malignant Neoplasms. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- 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. - 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.
Primary outcome measures
- Safe Success [Time frame: 30 Days]
Secondary outcome measures (9)
- Incidence of Post-ERCP Pancreatitis [Time frame: 30 days]
- Severity of Post-ERCP Pancreatitis [Time frame: 30 days]
- Overall ERCP-Related Adverse Events [Time frame: 30 days]
- Cannulation Time [Time frame: During the ERCP procedure]
- Total Procedure Time [Time frame: During the ERCP procedure]
- Need for Rescue Cannulation Technique [Time frame: During the ERCP procedure]
- Hyperamylasemia Without Clinical Pancreatitis [Time frame: At 24 hours after ERCP]
- Hospital Length of Stay [Time frame: Up to 30 days after ERCP]
- 30-Day All-Cause Readmission [Time frame: Up to 30 days after ERCP]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07329803 · PRIDE