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

Study Overview
=================
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.

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

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

Intervention / Treatment
-----------------
* Procedure: Double-guidewire cannulation technique


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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 DGT immediately and the delayed arm uses the DGT only if 10 more minutes of conventional cannulation technique does not allow biliary cannulation.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: early double-guidewire technique (DGT)<br>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. | Procedure: Double-guidewire cannulation technique<br>* 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.<br>|
| Active Comparator: delayed double-guidewire technique (DGT)<br>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. | Procedure: Double-guidewire cannulation technique<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biliary cannulation success rate | The percentage of biliary cannulation success in both arms. | During the ERCP procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immediate morbidity | Any complications (procedure related, clinical or anesthesiological) occurring during the procedure or during the immediate post-intervention period. | 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 | 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 from the first guidewire insertion into the pancreatic duct up to the end of cannulation. |