Comparative Efficacy and Safety of Needle-Knife Fistulotomy Vs. Standard Cannulation in Primary Biliary Access: a Practical Randomized Controlled Trial
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 186
- Locations
- 1
- Primary Endpoint
- post ERCP pancreatitis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •older than 18 years of age -
Exclusion Criteria
- •if unable to provide informed consent, pregnant, hemodynamically unstable, with a prior known history of biliary sphincterotomy or ampullectomy
Arms & Interventions
Standard Cannulation
Standard Biliary Cannulation
Intervention: standard biliary cannulation (Procedure)
NKF Cannulation
Biliary Cannulation using NKF technique
Intervention: Needle Knife Fistulotomy (Procedure)
Outcomes
Primary Outcomes
post ERCP pancreatitis
Time Frame: 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 Outcomes
- Perforation(within 48 hours)
- Bleeding(within 48 hours)