early gastric cancer
Conditions
Interventions
Sponsors
Yokohama City University Medical CenterGastroenterological Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) a biopsy-proven, differentiated adenocarcinoma, exclude undifferentiated adenocarcinoma. 2)initial and single lesion. 3)tumor depth confined to the mucosa. 4)endoscopically findings a) UL(-)group, any size b) UL(+)group, <=30mm 5) possible to enbloc resection 6) less possibility of stricture 7) no findings of any LN swelling, any metastasis on CT(N0,M0). 8) PS is 0 or 1. 9) no synchronus and/or metachronus carcinoma of stomach. 10) no histoly of any cancer. 11) a) WBC>=3,000/mm3 and <=12,000/mm3 b) Hb>=9.0g/dL c) Plt>=100,000/mm3 d) AST, ALT<=100 IU/L e) T-bil <=2.0mg/dL f) Cr<=2.0mg/dL 12)Voluntary signed and dated written informed consent from all the patients was obtained.
Exclusion criteria
Exclusion criteria: 1)continuous medication of anti- coagulate drugs 2)double cancer 3)Pregnant or lactating Women 4)Psychological conditions that may interfere with the patient's compliance and evaluation of the study results 5)Patients with continuous medication of steroid. 6) Patients with active clinically serious infection. 7) Active coronary artery disease less than 3 months prior to study entry 8)Patients with uncontrolled HT. 9)Patients with uncontrolled DM. 10)Patients with respiratory disease with HOT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5year overall survival rate (OS) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) OS at UL(-) group 2) OS at UL(+) group 3) Disease free survival rate 4) the rate of avoidance from gastrectomy 5) enbloc resection rate 6) Curative resection rate 7) side effect 8) serious side effect | — |
Countries
Japan
Contacts
Public ContactKingo Hirasawa
Yokohama City University Medical Center Gastroenterological Center
Outcome results
None listed