PPI for Prevention of Post-sphincterotomy Bleeding
- Registration Number
- NCT01873079
- Lead Sponsor
- The University of Hong Kong
- Brief Summary
Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.
- Detailed Description
Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy.
Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 185
Inclusion Criteria
- Consecutive patients undergoing ERCP who will require sphincterotomy
Exclusion Criteria
- Previous sphincterotomy/papillotomy
- Previous Polya gastrectomy
- Patients on maintenance PPI
- Pregnant and lactating women
- Age <18 years
- Previous liver transplant
- unable to consent for study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Esomeprazole Esomeprazole esomeprazole 40mg bd for 10 days Standard care Standard care No other study drug or placebo will be given
- Primary Outcome Measures
Name Time Method Proportion of patients with bleeding after sphincterotomy 10 days
- Secondary Outcome Measures
Name Time Method Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding 10 days
Trial Locations
- Locations (1)
Queen Mary Hospital
🇨🇳Hong Kong, China