Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

Detailed Description
-----------------
Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients. Type of study: Multicentric, prospective and randomized trial Patients: PEP high-risk patients underwent ERCP for benign biliary pathology Number of patients: 320 patients (160 for each group) Aim: Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.

Official Title
-----------------
Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients

Conditions
-----------------
Complications of Surgical and Medical Care: General Terms

Intervention / Treatment
-----------------
* Device: ERCP with loop tip wire
* Device: ERCP for cannulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk patients for post-ERCP pancreatitis Exclusion Criteria: age < 18 yrs allergy to the contrast medium previous surgery neoplastic bilio-pancreatic disease previous EBS

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ERCP with loop tip wire<br>ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis. | Device: ERCP with loop tip wire<br>* Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation<br>|
| Active Comparator: ERCP for cannulation<br>ERCP for cannulation of CBD with traditional technique | Device: ERCP for cannulation<br>* Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of the incidence of PEP |  | loop20216 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The evaluation of CBD percentage cannulation. |  | loop20216 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
loop, ERCP, cannulation, biliary, wire