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
Information source: Samsung Medical Center
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Delayed Bleeding
Intervention: high dose proton pump inhibitor (Drug); H2RB (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: Samsung Medical Center Overall contact:
Jae J Kim, professor, Phone: 82-2-3410-3409, Email: jjkim@skku.edu
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention
Primary outcome: bleeding incidence after ESD
Secondary outcome: the size of healing ulcer after ESD
Eligibility
Minimum age: 18 Years.
Maximum age: 80 Years.
Gender(s): Both.
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
Locations and Contacts
Jae J Kim, professor, Phone: 82-2-3410-3409, Email: jjkim@skku.edu
Samsung Medical Center, Seoul 82, Korea, Republic of; Recruiting
Jae J Kim, Professor, Phone: 82-2-3410-3409, Email: jjkim@skku.edu
Jae J Kim, Professor, Principal Investigator
Additional Information
Starting date: July 2009
Last updated: August 10, 2010
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