NCT03582540

Early Versus Delayed Double-guidewire Technique in Difficult Biliary Cannulation. (DFG)

Study Assessing the Interest of the Double-guidewire Technique for Catheterization of the Common Bile Duct.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective randomized comparative multicentric study. Briefly, we will analyze the technical success, performance and clinical outcomes of early versus delayed double-guidewire technique (DGT) in difficult biliary cannulation.

Detailed description

This is a prospective study performed in 20 tertiary medical centers in France. We aim to recruit 150 patients from 2016 to 2020. Patients with a native papilla scheduled for ERCP (endoscopic retrograde cholangiopancreatography) are screened for the study. Patients with a difficult biliary cannulation are included in the study if the guidewire is inserted in the pancreatic duct. At that point, patients are randomized in two arms: early versus delayed DGT. The early arm attempts biliary cannulation using the double-guidewire technique immediately and the delayed arm uses the double-guidewire technique only if 10 more minutes of standard cannulation technique does not allow biliary cannulation. The primary outcome is the biliary cannulation rate success. Secondary outcomes are complications rate and performance of the technique in both arms. Follow-up is 30 days.

Conditions

• Catheterization
• Cholangiopancreatography
• Endoscopic Retrograde Cholangiography
• Biliary Cannulation
• Difficult Biliary Cannulation
• Double-guidewire Technique

Interventions

Type	Name	Description
PROCEDURE	Double-guidewire cannulation technique	With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.

Timeline

• Start date: 2016-11-02
• Primary completion: 2019-07-30
• Completion: 2019-08-30
• First posted: 2018-07-11
• Last updated: 2019-09-23

Locations

8 sites across 1 country: France