Endoscopic Retrograde Cholangiopancreatography
Conditions
Keywords
The focus of the study is double-wire technique versus single wire technique in patients undergoing ERCP with biliary cannulation as the primary objective.
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.
Interventions
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Success of biliary cannulation | 10 minutes after randomization | The primary outcome is incidence of successful deep biliary cannulation within 10 minutes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States