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Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation

NCT02197338 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 498

Last updated 2016-04-15

No results posted yet for this study

Summary

1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer.
2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP).
3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages.
4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care.
5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation
6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.

Conditions

  • Cholestasis, Extrahepatic

Interventions

OTHER

Bile Duct Cannulation

Initial bile duct cannulation (first 8 attempts) will be made in each subject using one of the four cannulation strategies described in the 4 arms. The arm for each subject will be assigned by randomziation.

Sponsors & Collaborators

  • University of Southern California

    lead OTHER

Principal Investigators

  • James Buxbaum, MD · University of Southern California

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02197338 on ClinicalTrials.gov