A comparative study to verify the usefulness and safety of endoscopic sphincterotomy using (OptimosTM) and foreign-made sphincter incision (CleverCut3V)
Not Applicable
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0006201
- Lead Sponsor
- Yonsei University Health System, Gangnam Severance Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 104
Inclusion Criteria
1. Patients with original biliary papilla
2. Patients with or suspected of having biliary tract disease
3. Patients in need of endoscopic retrograde cholangiopancreatography for treatment
Exclusion Criteria
1.Under 19
2.Pregnant patients
3. Patients with reduced intelligence
4. Patients sensitive to contrast agents
5.Patients who had previously undergone papillary incision
6.Biliary papillary tumor patients
7.Patients who underwent hepatobiliary surgery
8.Patients who have difficulty endoscopically accessing the biliary papilla due to abdominal surgery (eg, gastrectomy, total gastrectomy)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Frequency and severity of complications (pancreatitis, bleeding, perforation, and infection) following papillary sphincter incision
- Secondary Outcome Measures
Name Time Method Success of biliary intubation by papillary sphincterotome, ease of biliary intubation, effectiveness of papillary incision, ease of contrast injection