Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP

Study Overview
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Brief Summary
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The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.

Detailed Description
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Sometimes, in the course of a regular ERCP procedure, techniques used by the doctor to pass a wire into the bile duct can result in the pancreas duct being entered instead. When this happens, the doctor may either remove the wire (known as single wire technique) or leave it in and use a second wire (double wire) to enter the bile duct. This study will try to determine whether the double wire technique or the single wire technique removing the wire is the safest and most efficient.

Official Title
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Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP

Conditions
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Endoscopic Retrograde Cholangiopancreatography

Intervention / Treatment
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* Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation
* Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing ERCP with primary intent to cannulate the bile duct Written informed consent Exclusion Criteria: Age < 18 years Non-naive papilla (previous sphincterotomy) Surgically altered anatomy Known/suspected pancreas divisum Suspected SOD/biliary manometry Prior ERCP/stent within 3 months ERCP performed in the Operating Room or at Duke North Pregnancy/breast-feeding

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single wire technique<br>single wire technique in patients undergoing ERCP with biliary cannulation | Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation<br> <br> |
| Active Comparator: Double wire technique<br>double-wire technique in patients undergoing ERCP with biliary cannulation | Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of biliary cannulation | The primary outcome is incidence of successful deep biliary cannulation within 10 minutes. | 10 minutes after randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of biliary cannulation | Number of attempts required for successful biliary cannulation | 2 days after the procedure | 
| Time to successful biliary cannulation |  | 2 days after the procedure | 
| Post-ERCP pancreatitis |  | 2 days after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.