Advanced gastric cancer
Conditions
Interventions
Laparoscopic gastrectomy
Sponsors
Department of Gastroenterological Surgery, Osaka University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Histologically proven gastric carcinoma (2)cStageII or III according to the Japanese Classification of Gastric Carcinoma [The 14th Edition] (3)R0 resection or R1 resection solely by CY1 can be obtained (4)Clinical H0, P0, M0 (5)No invasion to esophagus and duodenum (6)No apparent invasion to adjacent organs (7) No prior treatment of chemotherapy for gastric cancer (8)The macroscopic tumor type is neither Borrmann type 4 (linitis plastica) nor large (8 cm or more) type 3 (9) Aged 20 to 79 years (10)Eastern Cooperative Oncology Group (ECOG) PS of 0-2 (11)Body mass index less than 30 (12)No obvious organ failures and satisfy the following laboratory data within 30 days before registration: WBC >=3,000/mm3 WBC<12,000/mm3 Platelet >= 100,000/mm3 Hb >= 8.0 g/dL AST <= local reference range 2 ALT <= local reference range 2 T.Bil <= 2.0 mg/dL Creatinin <= 1.5 mg/dL (13)No history of upper abdominal surgery and no history of intestinal resection. (14)No prior treatment of chemotherapy or radiation therapy against any other malignancies. (15)provided written informed consent
Exclusion criteria
Exclusion criteria: (1)Synchronous or metachronous (within 5 years) malignancies other than carcinoma in situ (2)Active infection disease (3)Over 38.0 degree Celsius (4)Women during pregnancy or breast-feeding. (5)Severe mental disease. (6)Continuous systemic steroid therapy. (7)History of myocardial infarction or unstable angina pectoris within six months. (8)Uncontrollable hypertension. (9)Uncontrollable diabetes millutus or administration of insulin. (10)Severe respiratory disease requiring continuous oxygen therapy. (11)Kidney failure requiring hemodialysis or peritoneal dialysis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Grade 3 or higher surgical complications (Clavien-Dindo Classification) | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of conversion to open surgery, performance of surgery, number of retrieved lymph node, adverse events, short-term clinical outcomes, completion rate of adjuvant chemotherapy, CEA mRNA in the peritoneal lavage fluid, overall survival, recurrence-free survival | — |
Countries
Japan
Contacts
Public ContactAtsushi Gakuhara
Osaka University School of Medicine Gastroenterological Surgery
Outcome results
None listed