Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
- Conditions
- Biliary Obstruction Due to Common Bile Duct StoneMalignant Bile Duct Obstruction
- Registration Number
- NCT06694038
- Lead Sponsor
- Thomas Jefferson University
- Brief Summary
Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
older than 18 years of age -
if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method post ERCP pancreatitis within 48 hours of the procedure Incidence of post ERCP pancreatitis defined as epigastric abdominal pain with lipase more than three times the upper limit of normal occurring within 48 hours of the procedure
- Secondary Outcome Measures
Name Time Method Perforation within 48 hours Perforation, defined by a full thickness defect either seen during endoscopy or on radiological studies post procedure.
Bleeding within 48 hours Significant bleeding was defined as a need for transfusion and/or need for repeat endoscopy for hemostasis
Trial Locations
- Locations (1)
Thomas Jefferson University Hospial
🇺🇸Philadelphia, Pennsylvania, United States