Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation
Completed · Not applicable
Conditions studied: Cholestasis, Extrahepatic
In brief
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.
Key facts
- Study ID
- NCT02197338
- Run by
- University of Southern California
- People needed
- 498
- Starts
- 2016-04-01
- Expected to finish
- 2016-04-01
- Last updated by the study team
- 2016-04-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Undergoing ERCP at LAC+USC Medical Centers for standard indications including bile duct stones, bile leak, and biliary obstruction will be included.
You may not qualify if…
- Prior ERCP with sphincterotomy
- Prior ERCP with failed bile duct cannulation
- Pregnant, imprisoned, under age 18, unable to give informed consent
- Prior biliary diversion surgery will be excluded
- Those who require ERCP only for pancreatic duct indications will also be excluded as bile duct cannulation is not clinically necessary in this group
Where it is running
- Los Angeles County Hospital — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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