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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

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ClinicalTrials.gov Identifier: NCT01179724
Recruitment Status : Unknown
Verified June 2009 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : August 11, 2010
Last Update Posted : August 11, 2010
Sponsor:
Information provided by:

Study Description
Brief Summary:
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

Condition or disease Intervention/treatment
Delayed Bleeding Drug: high dose proton pump inhibitor Drug: H2RB

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : July 2009
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: curan


Outcome Measures

Primary Outcome Measures :
  1. bleeding incidence after ESD [ Time Frame: time to occur delayed bleeding within one month after ESD ]

Secondary Outcome Measures :
  1. the size of healing ulcer after ESD [ Time Frame: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

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): NCT01179724


Contacts
Contact: Jae J Kim, professor 82-2-3410-3409 jjkim@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 82
Contact: Jae J Kim, Professor    82-2-3410-3409    jjkim@skku.edu   
Principal Investigator: Jae J Kim, Professor         
Sponsors and Collaborators
Samsung Medical Center
More Information

Responsible Party: Samsung Medical Center IRB, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179724     History of Changes
Other Study ID Numbers: 2009-06-030
First Posted: August 11, 2010    Key Record Dates
Last Update Posted: August 11, 2010
Last Verified: June 2009

Additional relevant MeSH terms:
Neoplasms
Hemorrhage
Stomach Neoplasms
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Pantoprazole
Proton Pump Inhibitors
Histamine H2 Antagonists
Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Physiological Effects of Drugs