early gastric cancer/gastric adenoma
Conditions
Interventions
second-look endoscopy will be performed after gastric ESD
second-look endoscopy will not be performed after gastric ESD
Sponsors
Graduate School of Medicine, University of Tokyo
National Cancer Center Hospital East, Osaka Medical Center for Cancer and Cardiovascular Diseases, Cancer Institute Hospital, National Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Clinical diagnosis of Stage IA gastric cancer or gastric adenoma, and highly suspicion of Stage IA gastric cancer. 2) With only one lesion which will be treated endoscopically. 3) Aged 20 years old or over. 4) PS (ECOG) of 0 to 2. 5) Meet all of the following criteria without blood transfusion in the past 14 days. i) Hb: >=9g/dl ii) Plt: >=100000/mm3 iii) AST, ALT: <=100 iv) Cre: <=2.0mg/dl v) PT%: >=80% vi) APTT: <=40sec 6) Available to be observed more than 28 days after ESD. 7) With 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) With a scheduled endoscopic treatment for esophageal lesion or duodenal lesion concurrently. 4) History of endoscopic treatment for upper GI lesion in the past 28 days. 5) With a scheduled endoscopic treatment for upper GI lesion in 28 days after gastric ESD. 6) With an allergy to proton pomp inhibitor. 7) Systemic administration (intravenously or orally) of either one or more drugs of corticosteroid, anticoagulant agent or antiplatelet agent. 8) Systemic administration of non-steroid anti-inflammatory drug which cannot be suspended through 7 days before to 28 days after gastric ESD. 9) Pregnant or lactation woman. 10) Diagnosis of psychosis. 11) With active bacterial or fungus infection. 12) History of myocardial infarction or unstable angina pectoris within 3 months. 13) With uncontrollable hypertension. 14) 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)late post-ESD bleeding rate (from 2 days after ESD to 28 days after ESD) 2)post-ESD bleeding rate classified by tumor location, tumor size and ulcerative findings 3)blood transfusion rate after ESD 4)risk factor for post-ESD bleeding 5)coagulation procedure rate during the second-look endoscopy | — |
Countries
Japan
Outcome results
None listed