Bleeding, ERCP
Conditions
Keywords
ERCP, sphincterotomy, proton pump inhibitor
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.
Interventions
DRUGEsomeprazole
OTHERStandard care
No PPI or other study medication given
Sponsors
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with bleeding after sphincterotomy | 10 days |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding | 10 days |
Countries
China
Outcome results
None listed