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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Delayed Bleeding

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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high dose proton pump inhibitor

Group Type EXPERIMENTAL

high dose proton pump inhibitor

Intervention Type DRUG

IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month

H2 receptor antagonist

Group Type ACTIVE_COMPARATOR

H2RB

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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pantoprazole curan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No