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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01179724
First received: August 10, 2010
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention
Delayed Bleeding
Drug: high dose proton pump inhibitor
Drug: H2RB

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • bleeding incidence after ESD [ Time Frame: time to occur delayed bleeding within one month after ESD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the size of healing ulcer after ESD [ Time Frame: follow up endoscopy for the healing of iatrogenic ulcer after one month ESD ] [ Designated as safety issue: No ]

Estimated Enrollment: 206
Study Start Date: July 2009
Estimated Study Completion Date: September 2010
Estimated Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Samsung Medical Center IRB, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01179724     History of Changes
Other Study ID Numbers: 2009-06-030
Study First Received: August 10, 2010
Last Updated: August 10, 2010
Health Authority: South Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 17, 2014