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

Société Française d'Endoscopie Digestive

Status: Completed

Conditions: Biliary Cannulation; Double-guidewire Technique; Endoscopic Retrograde Cholangiography; Catheterization; Cholangiopancreatography; Difficult Biliary Cannulation

Treatments: Procedure: Double-guidewire cannulation technique

Study type: Interventional

Funder types: Other

Identifiers

NCT03582540

ID RCB: 2016-A01016-45

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

150 participants in 2 patient groups

early double-guidewire technique (DGT)

Active Comparator group

Description:

First arm: early double-guidewire technique The early arm attempts biliary cannulation using the DGT immediately once the guidewire is inserted in the pancreatic duct in cases of difficult biliary cannulation.

Treatment:

Procedure: Double-guidewire cannulation technique

delayed double-guidewire technique (DGT)

Active Comparator group

Description:

In the delayed arm, once the guidewire is inserted in the pancreatic duct, the operator continues to attempt biliary cannulation with conventional technique (contrast- or guidewire-assisted). DGT is used only if 10 more minutes of conventional cannulation technique does not allow biliary access.

Treatment:

Procedure: Double-guidewire cannulation technique