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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2015-06-30

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.

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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.

Conditions

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Endoscopic Retrograde Cholangiopancreatography

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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single wire technique

single wire technique in patients undergoing ERCP with biliary cannulation

Group Type ACTIVE_COMPARATOR

single-wire technique in patients undergoing ERCP with biliary cannulation

Intervention Type PROCEDURE

Double wire technique

double-wire technique in patients undergoing ERCP with biliary cannulation

Group Type ACTIVE_COMPARATOR

double-wire technique in patients undergoing ERCP with biliary cannulation

Intervention Type PROCEDURE

Interventions

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double-wire technique in patients undergoing ERCP with biliary cannulation

Intervention Type PROCEDURE

single-wire technique in patients undergoing ERCP with biliary cannulation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing ERCP with primary intent to cannulate the bile duct
2. Written informed consent

Exclusion Criteria

1. Age \< 18 years
2. Non-naive papilla (previous sphincterotomy)
3. Surgically altered anatomy
4. Known/suspected pancreas divisum
5. Suspected SOD/biliary manometry
6. Prior ERCP/stent within 3 months
7. ERCP performed in the Operating Room or at Duke North
8. Pregnancy/breast-feeding

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No