Back to resultsPPI for Prevention of Post-sphincterotomy Bleeding
Primary Purpose
Bleeding, ERCP
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Esomeprazole
Standard care
Sponsored by
About this trial
This is an interventional prevention trial for Bleeding focused on measuring ERCP, sphincterotomy, proton pump inhibitor
Eligibility Criteria
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
Sites / Locations
- Queen Mary Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Esomeprazole
Standard care
Arm Description
esomeprazole 40mg bd for 10 days
No other study drug or placebo will be given
Outcomes
Primary Outcome Measures
Proportion of patients with bleeding after sphincterotomy
Secondary Outcome Measures
Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding
Full Information
NCT ID
NCT01873079
First Posted
June 5, 2013
Last Updated
July 15, 2016
Sponsor
The University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT01873079
Brief Title
PPI for Prevention of Post-sphincterotomy Bleeding
Official Title
Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bleeding, ERCP
Keywords
ERCP, sphincterotomy, proton pump inhibitor
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esomeprazole
Arm Type
Active Comparator
Arm Description
esomeprazole 40mg bd for 10 days
Arm Title
Standard care
Arm Type
Sham Comparator
Arm Description
No other study drug or placebo will be given
Intervention Type
Drug
Intervention Name(s)
Esomeprazole
Other Intervention Name(s)
Nexium
Intervention Type
Other
Intervention Name(s)
Standard care
Intervention Description
No PPI or other study medication given
Primary Outcome Measure Information:
Title
Proportion of patients with bleeding after sphincterotomy
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding
Time Frame
10 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai K Leung, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
China
12. IPD Sharing Statement
Learn more about this trial
PPI for Prevention of Post-sphincterotomy Bleeding
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