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

Not Applicable

Completed

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

• Registration Number: NCT03582540
• Lead Sponsor: Société Française d'Endoscopie Digestive

Brief 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.

Study Timeline

• Study Start: 2016-11-02
• Status Verified: 2018-06
• Study First Submitted: 2018-06-28
• Study First Submitted QC: 2018-07-10
• Study First Posted: 2018-07-11
• Primary Completion: 2019-07-30
• Study Completion: 2019-08-30
• Last Update Submitted: 2019-09-20
• Last Update Posted: 2019-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Biliary cannulation success rate	During the ERCP procedure	The percentage of biliary cannulation success in both arms.

Secondary Outcome Measures

Name	Time	Method
Immediate morbidity	From the start, until 30 minutes after completion of ERCP	Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.
Delayed morbidity	30 minutes after ERCP completion and up to 30 days	Morbidities occurring more than 30 minutes and up to 1 month after ERCP completion. Special attention will be taken for bowel perforation, gastrointestinal bleeding and acute pancreatitis
procedural time	time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.	The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.

Trial Locations

Locations (8)

Clinique de Bercy; 🇫🇷 Charenton-le-Pont, France

Hôpital Dupuytren; 🇫🇷 Limoges, France

Hopital Saint Joseph; 🇫🇷 Marseille, France

Groupe Hospitalier Diaconesses - La Croix Saint-Simon; 🇫🇷 Paris, France

Hôpital Haut Lévêque; 🇫🇷 Pessac, France

Centre Hospitalier Lyon Sud; 🇫🇷 Pierre-Bénite, France

Centre Hospitalier de Bigorre; 🇫🇷 Tarbes, France

Centre Hospitalier de Vichy; 🇫🇷 Vichy, France