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PPI for Prevention of Post-sphincterotomy Bleeding

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ClinicalTrials.gov Identifier: NCT01873079
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : July 18, 2016
Sponsor:
Information provided by (Responsible Party):
LEUNG Wai Keung, The University of Hong Kong

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
Bleeding ERCP Drug: Esomeprazole Other: Standard care 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.


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Study Type : Interventional  (Clinical Trial)
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 : April 2013
Actual Primary Completion Date : March 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

Arm Intervention/treatment
Active Comparator: Esomeprazole
esomeprazole 40mg bd for 10 days
Drug: Esomeprazole
Other Name: Nexium

Sham Comparator: Standard care
No other study drug or placebo will be given
Other: Standard care
No PPI or other study medication given




Primary Outcome Measures :
  1. Proportion of patients with bleeding after sphincterotomy [ Time Frame: 10 days ]

Secondary Outcome Measures :
  1. Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding [ Time Frame: 10 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873079


Locations
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China
Queen Mary Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Investigators
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Principal Investigator: Wai K Leung, MD The University of Hong Kong

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Responsible Party: LEUNG Wai Keung, Clinical Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT01873079     History of Changes
Other Study ID Numbers: ERCP-PPI ver. 2
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by LEUNG Wai Keung, The University of Hong Kong:
ERCP
sphincterotomy
proton pump inhibitor

Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes
Esomeprazole
Proton Pump Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action