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.

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.

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.

Inclusion Criteria:

• Patients 18 years old and more
• Native papilla
• Clinical indications of ERCP
• Difficult biliary cannulation defined by unintentional guidewire insertion into the pancreatic duct before biliary cannulation is successful
• Informed consent completed by the patient

Exclusion Criteria:

• Contraindication to upper gastrointestinal endoscopy
• ERCP with direct biliary cannulation success
• ERCP with inability to cannulate the bile duct nor the pancreatic duct
• Coagulation or hemostasis disorder (TP < 60%, TCA> 40 sec. et plaquettes < 60000/mm3).
• Patient under active antiaggregant or anticoagulant medication other than aspirin
• Endoscopic treatment of chronic pancreatitis
• Pregnancy or breastfeeding
• ERCP performed by another operator than an investigator
• Patient's voluntary withdrawal
• Withdrawal decision by the investigator or sponsor