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

Not Applicable
Completed
Conditions
Endoscopic Retrograde Cholangiopancreatography
Interventions
Procedure: single-wire technique in patients undergoing ERCP with biliary cannulation
Procedure: 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
Inclusion Criteria
  1. Patients undergoing ERCP with primary intent to cannulate the bile duct
  2. Written informed consent
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
single wire techniquesingle-wire technique in patients undergoing ERCP with biliary cannulationsingle wire technique in patients undergoing ERCP with biliary cannulation
Double wire techniquedouble-wire technique in patients undergoing ERCP with biliary cannulationdouble-wire technique in patients undergoing ERCP with biliary cannulation
Primary Outcome Measures
NameTimeMethod
Success of biliary cannulation10 minutes after randomization

The primary outcome is incidence of successful deep biliary cannulation within 10 minutes.

Secondary Outcome Measures
NameTimeMethod
Success of biliary cannulation2 days after the procedure

Number of attempts required for successful biliary cannulation

Time to successful biliary cannulation2 days after the procedure
Post-ERCP pancreatitis2 days after the procedure

Trial Locations

Locations (1)

Duke University Medical Center

🇺🇸

Durham, North Carolina, United States

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