Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02297750
Enrollment
161
Registered
2014-11-21
Start date
2012-08-31
Completion date
2015-06-30
Last updated
2015-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Retrograde Cholangiopancreatography

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

PROCEDUREdouble-wire technique in patients undergoing ERCP with biliary cannulation
PROCEDUREsingle-wire technique in patients undergoing ERCP with biliary cannulation

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Success of biliary cannulation10 minutes after randomizationThe primary outcome is incidence of successful deep biliary cannulation within 10 minutes.

Secondary

MeasureTime frameDescription
Success of biliary cannulation2 days after the procedureNumber of attempts required for successful biliary cannulation
Time to successful biliary cannulation2 days after the procedure
Post-ERCP pancreatitis2 days after the procedure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026