NCT01873079

PPI for Prevention of Post-sphincterotomy Bleeding

Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 185 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bleeding
• ERCP

Interventions

Type	Name	Description
DRUG	Esomeprazole
OTHER	Standard care	No PPI or other study medication given

Timeline

• Start date: 2013-04-01
• Primary completion: 2016-03-01
• Completion: 2016-06-01
• First posted: 2013-06-07
• Last updated: 2016-07-18

Locations

1 site across 1 country: China