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PPI for Prevention of Post-sphincterotomy Bleeding

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT01873079
Collaborator
(none)
185
Enrollment
1
Location
2
Arms
38
Duration (Months)
4.9
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
185 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor
Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Mar 1, 2016
Actual Study Completion Date :
Jun 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Esomeprazole

esomeprazole 40mg bd for 10 days

Drug: Esomeprazole
Other Names:
  • Nexium

    		•
    Sham Comparator: Standard care

    No other study drug or placebo will be given

    Other: Standard care
    No PPI or other study medication given

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of patients with bleeding after sphincterotomy [10 days]

    Secondary Outcome Measures

    1. Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding [10 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Queen Mary Hospital Hong Kong China

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    • Principal Investigator: Wai K Leung, MD, The University of Hong Kong

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT01873079
    Other Study ID Numbers:
    • ERCP-PPI ver. 2
    First Posted:
    Jun 7, 2013
    Last Update Posted:
    Jul 18, 2016
    Last Verified:
    Jul 1, 2016
    Keywords provided by LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
    ERCP
    sphincterotomy
    proton pump inhibitor
    Additional relevant MeSH terms:
    Hemorrhage
    Esomeprazole

    Study Results

    No Results Posted as of Jul 18, 2016