Ballooning time after small sphincterotomy
Phase 1
- Conditions
- Choleducolithiasis.Calculus of bile duct without cholangitis or cholecystitis
- Registration Number
- IRCT2013033112877N1
- Lead Sponsor
- Vice Chancellor for Research, Isfahan University of Medical Sciences and Health Services
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
16 to 90 years old patients eligible for treatment of choleducolithiasis documented with ultrasonography or magnetic resonance cholangiopancreatography, no severe hepatic or systemic disease, no history of gastric or choledochal surgery (except cholecystectomy), no active pancreatitis, no previous sphincterotomy, no biliary stricture, no choledochal cyst, no addiction. Exclusion criteria: precut sphincterotomy, failure of cannulation of common hepatic duct, no stone in endoscopic retrograde cholangiopancreatography, lack of consent to cooperate in trial.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Common Bile Duct stone clearance. Timepoint: Just after the intervention. Method of measurement: Observation (stone or stones extraction).
- Secondary Outcome Measures
Name Time Method Abdominal pain. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination.;Fever. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: Oral thermometer, temperature equal or more than 38 degree of Celsius.;Serum amylase level. Timepoint: Before and 2 hours after the intervention. Method of measurement: ELISA kits: International Unit per Littre.;Hemorrhage. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination.;Perforation. Timepoint: Every six hours up to 48 hours after the intervention. Method of measurement: History and physical examination.;Pancreatitis. Timepoint: Every six hours up to 24 hours after the intervention. Method of measurement: History, physical examination and serum amylase 2 hours after the procedure.