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

Société Française d'Endoscopie Digestive150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Catheterization Cholangiopancreatography

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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

Outcomes

Primary Outcomes

Biliary cannulation success rate

The percentage of biliary cannulation success in both arms.

Time frame: During the ERCP procedure

Secondary Outcomes

Immediate morbidity

Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period.

Time frame: From the start, until 30 minutes after completion of ERCP

Delayed morbidity

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

Time frame: 30 minutes after ERCP completion and up to 30 days

procedural time

The time taken in minutes between patient randomization (at the first guidewire insertion into the pancreatic duct) and successful biliary cannulation.

Time frame: time from the first guidewire insertion into the pancreatic duct up to the end of cannulation.