Comparison of Proton Pump Inhibitor and H2 Receptor Blocker on Prevention of Bleeding From Iatrogenic Ulcer After Endoscopic Submucosal Dissection for Gastric Neoplasms: A Prospective Randomized Controlled Trial

August 10, 2010 updated by: Samsung Medical Center
after endoscopic submucosal dissection(ESD) of early gastric cancer, conventional proton pump(PPI) inhibitors and H2 receptor antagonists have a controversial effect on preventing bleeding from artificial ulcers. the aim of this study was to investigate whether a stronger acid suppression (high dose PPI) more effectively prevents bleeding after ESD

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

206

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jae J Kim, Professor
  • Phone Number: 82-2-3410-3409
  • Email: jjkim@skku.edu

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 82
        • Recruiting
        • Samsung Medical Center
        • Contact:
          • Jae J Kim, Professor
          • Phone Number: 82-2-3410-3409
          • Email: jjkim@skku.edu
        • Principal Investigator:
          • Jae J Kim, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • the patients who agreed informed consent
  • gastric adenoma or early gastric cancer which is eligible for conventional ESD indication

Exclusion Criteria:

  • recent drug history of PPI, H2 rector antagonist, bismuth and antibiotics within 4 weeks
  • recent drug history of anticoagulant or antiplatelet agent within 7 days
  • s/p subtotal gastrectomy
  • recurred gastric adenoma or cancer
  • pregnant or breast feeding patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: high dose proton pump inhibitor
Drug: high dose proton pump inhibitor
IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month
Other Names:
  • pantoprazole
ACTIVE_COMPARATOR: H2 receptor antagonist
Drug: H2RB
IV 50mg loading H2 receptor antagonist before 2hr to conduct ESD, and IV 13mg/h continuous infusion within 48hr, and then 300mg oral H2 receptor antagonist for one month
Other Names:
  • curan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
bleeding incidence after ESD
Time Frame: time to occur delayed bleeding within one month after ESD
time to occur delayed bleeding within one month after ESD

Secondary Outcome Measures

Outcome Measure
Time Frame
the size of healing ulcer after ESD
Time Frame: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD
follow up endoscopy for the healing of iatrogenic ulcer after one month ESD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ANTICIPATED)

September 1, 2010

Study Completion (ANTICIPATED)

September 1, 2010

Study Registration Dates

First Submitted

August 10, 2010

First Submitted That Met QC Criteria

August 10, 2010

First Posted (ESTIMATE)

August 11, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 11, 2010

Last Update Submitted That Met QC Criteria

August 10, 2010

Last Verified

June 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2009-06-030

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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