Initial use of Rotatable sphincterotome facilitates selective bile duct cannulation compared with use of conventional sphincterotome: a prospective randomized controlled trial of papillotome.
Phase 1
- Conditions
- Of all diseases needed to perform ERC.
- Registration Number
- JPRN-UMIN000018032
- Lead Sponsor
- Kitano Hospital, The Tazuke Kofukai Medical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1. In patients with ECOG Perfoemance Status Grade 4. 2. In patients with impaired consciousness. 3. In patients with suspected pancreatobiliary maljunction. 4. In patients with previous gastrectomy with Billroth II or Roux-en-Y reconstruction. 5. In patients with acute pancreatitis 6. In patients with impacted stone or tumor of ampulla of Vater. 7. In patients with bilioduodenal fistula opening around the papilla
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is successful selective bile duct cannulation within 10 miniutes and 10 times after randomization.
- Secondary Outcome Measures
Name Time Method The secondary endpoints are successful final selective bile duct cannulation rates, procedure success rate, selective bile duct cannulation time, number of attempts at bile duct cannulation, number of accidental pancreatic duct insertions, procedure time, radiation exposure time, use of precutting for selective bile duct cannulation, and complications including PEP rates in the randomized patients and also in the initially enrolled cohort.