Resectable gastric cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Histologically proven gastric carcinoma 2) Resectable gastric cancer 3) Not applicable of ESD according to the Japanese classification 4) Excluding esophageal invasion (thoracic esophagus) or duodenal invasion (second portion) 5) Aged 20 to 90 year 6) PS (ECOG) 0 or 1 7) BMI < 35 8) No history of gastrointestinal surgery 9) No history of chemotherapy or radiotherapy 10) Normal function of the major organs; indicated by a leukocyte count of over 3000 mm3, a platelet count of over 100 000 mm3, aspartate aminotransferase and alanine aminotransferase levels less than 200 IU/L, total bilirubin less than 3 g/dl and creatinine levels less than 2 mg/dl. 11) Proven written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous malignancies other than carcinoma in situ 2) Pregnancy or breast-feeding 3) Severe mental disease 4) Continuous systemic steroid therapy 5) History of myocardial infarction or unstable angina pectoris within six months 6) Uncontrollable hypertension 7) Uncontrollable diabetes mellitus or administration of insulin 8) Respiratory disease requiring continuous oxygen therapy 9) History of deep vein thrombosis 10)Doctors decision not to register to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of intra-abdominal infectious complications (pancreatic fistula, intra-abdominal abscess, and anastomotic leakage) with more than Clavien-Dindo grade 2 | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of postoperative complications, duration of surgery, blood loss, blood transfusion, time to first oral intake, length of stay, relapse-free survival, overall survival rate | — |
Countries
Japan
Contacts
Wakayama Medical University, School of Medicine Second Department of Surgery