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A randomized phase II study to assess the efficacy of acid blocker on prevention of hemorrhage and healing of ulcers after endoscopic submucosal dissection(ESD) for gastric neoplasms

Phase 2
Conditions
early gastric cancer/gastric adenoma
Registration Number
JPRN-UMIN000017320
Lead Sponsor
Osaka Medical Center for Cancer and Cardiovascular Diseases
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
140
Inclusion Criteria

Not provided

Exclusion Criteria

1) History of gastrectomy or reconstruction of gastric tube. 2) History of radiation therapy to the upper abdominal region. 3) Undifferentiated-type cancer 4) Schedule of endoscopic treatment for esophageal or duodenal lesion concurrently. 5) History of endoscopic treatment for upper GI lesion in the past 28 days. 6) Schedule of endoscopic treatment for upper GI lesion within 28 days after the gastric ESD. 7) Allergy to vonoprazan and lansoprazole. 8) Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent or antiplatelet agent. 9) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after gastric ESD. 10) Pregnant or lactation woman. 11) Diagnosis of psychiatric diseases. 12) With active bacterial or fungus infection. 13) History of myocardial infarction or unstable angina pectoris within 3 months. 14) With uncontrollable hypertension. 15) With severe respiratory disease requiring continuous oxygen therapy.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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