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

Samsung Medical Center

Status: Unknown

Conditions: Delayed Bleeding

Treatments: Drug: H2RB; Drug: high dose proton pump inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT01179724

2009-06-030

Details and patient eligibility

About

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

Enrollment: 206 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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206 participants in 2 patient groups

high dose proton pump inhibitor

Experimental group

Treatment:

Drug: high dose proton pump inhibitor

H2 receptor antagonist

Active Comparator group

Treatment:

Drug: H2RB