At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized Controlled Trial of Short Versus Long Wire and Small Versus Standard Sphincterotomes for Initial Biliary Cannulation
In Brief
A clinical study evaluating Bile Duct Cannulation for Cholestasis, Extrahepatic. Completed, enrolled 498 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
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.