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

Duke University

Status: Completed

Conditions: Endoscopic Retrograde Cholangiopancreatography

Treatments: Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation; Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02297750

Pro00033706

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

161 participants in 2 patient groups

single wire technique

Active Comparator group

Description:

single wire technique in patients undergoing ERCP with biliary cannulation

Treatment:

Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation

Double wire technique

Active Comparator group

Description:

double-wire technique in patients undergoing ERCP with biliary cannulation

Treatment:

Procedure: double-wire technique in patients undergoing ERCP with biliary cannulation