Patients with Stage IA early gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Biopsy specimen from the primary lesion shows adenocarcinoma 2) Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography 3) Endoscopic submucosal dissection is not indicated 4) Tumor was located within lower two thirds of stomach 5) Not having duodenal invasion 6) Eeatern clinical oncology group performans status is 0 or 1 7) Body mass index is lower than 30 8) No previous laparotomy 9) No previous chemotherapy or radiation including those for other cancers 10) Fulfil all following conditions WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl
Exclusion criteria
Exclusion criteria: 1) Having other active cancers 2) Possibly pregnant, or breast feeding woman 3) with psychiatric disorder 4) Receiving steroids 5) With Acute myocardial infaction in 6 months or with unstable ungina 6) With uncontrolled hypertention 7) With uncontrolled diabetes mellitus 8) With pulmonary disease and require continuous oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of post-operative intra-abdominal infectious complications (anastomotic leakage, pancreas related infection, and intra-abdominal abscess) | — |
Secondary
| Measure | Time frame |
|---|---|
| Oveall survival Relapse free survival Completion rate of robot assised surgery The incidence of adverse event | — |
Countries
Japan
Contacts
Sizuoka Cancer Center Division of Gastric Surgery