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A Phase III trial of inhibitory effect of metachronous gastric cancer by Helicobacter pylori eradication for patients after endoscopic submucosal dissectio

Not Applicable
Conditions
Early gastric cancer
Registration Number
JPRN-UMIN000018403
Lead Sponsor
Shizuoka Cancer Center
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
1000
Inclusion Criteria

Not provided

Exclusion Criteria

(1) synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ (2) Infectious disease with systemic therapy indicated. (3) Body temperature of 38 or more degrees Celsius. (4) pregnant or breast-feeding women (5) Severe psychiatric disease. (6) Continuous systemic steroid therapy. (7) Unstable angina pectoris, or history of myocardial infarction within six months. (8) Poorly controlled hypertension. (9) Severe respiratory disease requiring continuous oxygen therapy. (10)Penicillin allergy (11) Poorly controlled diabetes mellitus in spite of continuous use of insulin.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
The proportion of 5 -year cumulative metachronous gastric cancer
Secondary Outcome Measures
NameTimeMethod
The proportion of 5 -year cumulative metachronous gastric cancer according to pepsinogen levels The proportion of annual cumulative metachronous gastric cancer Overall survival time Disease free survival time The proportion of the incidence of reflux esophagitis The proportion of exacerbation of reflux esophagitis
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