early gastric cancer/gastric adenoma
Conditions
Interventions
Vonoprazan administration
Lansoprazole administration
Sponsors
Osaka Medical Center for Cancer and Cardiovascular Diseases
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinical diagnosis of Stage IA gastric cancer or gastric adenoma, and suspicion for Stage IA gastric cancer or gastric adenoma. 2) Performance of endoscopic treatment for only one lesion. 3) 20 years old or older. 4) Performance status (ECOG) of 0 to 2. 5) Meeting all of the following criteria without blood transfusion in the past 14 days. i) Hb: >=9g/dl ii) Plt: >=100000/mm3 iii) AST, ALT: <=100U/l iv) Cre: <=2.0mg/dl v) PT%: >=70% 6) Available to be observed more than 28 days after ESD. 7) Written informed consent.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-ESD bleeding rate (soon after ESD to 28 days after ESD) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Healing rate of ulcer at follow - up endoscopy (56 days after ESD +- 3 days) 2) Post-ESD bleeding rate according to tumor location, tumor size and ulcerative findings (soon after ESD to 28 days after ESD) | — |
Countries
Japan
Contacts
Public ContactKazuyuki Ito
Osaka Medical Center for Cancer and Cardiovascular Diseases Research Center, Osaka Medical Center for Cancer and Cardiovascular Diseases
Outcome results
None listed