Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
- Conditions
- Endoscopic Retrograde Cholangiopancreatography
- Interventions
- Procedure: single-wire technique in patients undergoing ERCP with biliary cannulationProcedure: double-wire technique in patients undergoing ERCP with biliary cannulation
- Registration Number
- NCT02297750
- Lead Sponsor
- Duke University
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 161
- Patients undergoing ERCP with primary intent to cannulate the bile duct
- Written informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description single wire technique single-wire technique in patients undergoing ERCP with biliary cannulation single wire technique in patients undergoing ERCP with biliary cannulation Double wire technique double-wire technique in patients undergoing ERCP with biliary cannulation double-wire technique in patients undergoing ERCP with biliary cannulation
- Primary Outcome Measures
Name Time Method Success of biliary cannulation 10 minutes after randomization The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.
- Secondary Outcome Measures
Name Time Method Success of biliary cannulation 2 days after the procedure Number of attempts required for successful biliary cannulation
Time to successful biliary cannulation 2 days after the procedure Post-ERCP pancreatitis 2 days after the procedure
Trial Locations
- Locations (1)
Duke University Medical Center
🇺🇸Durham, North Carolina, United States