PPI for Prevention of Post-sphincterotomy Bleeding

Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01873079
• Other study ID #: ERCP-PPI ver. 2
• Status: Completed
• Phase: Phase 3
• First received: June 5, 2013
• Last updated: July 15, 2016
• Start date: April 2013
• Est. completion date: June 2016

Study information

• Verified date: July 2016
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 185
• Est. completion date: June 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Bleeding
• ERCP
• Hemorrhage

Intervention

Drug:
• Esomeprazole

Other:
• Standard care
No PPI or other study medication given

Locations

Country	Name	City	State
China	Queen Mary Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of patients with bleeding after sphincterotomy		10 days	No
Secondary	Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding		10 days	No