cT2 (MP) - T4a (SE) gastric cancer invading the greater curvature
Conditions
Interventions
Laparoscopic/robotic spleen-preserving splenic hilar dissection
Sponsors
Japan Clinical Oncology Group (JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)Histologically proven gastric adenocarcinoma by endoscopic biopsy. 2)Clinical T2(MP)-T4a(SE) located in the U area of the stomach and invading the greater curvature (Gre). 3)No swollen lymph nodes detected by CT scan at the splenic hilum larger than 10 mm in diameter in major axis or 8 mm in diameter in minor axis. No direct invasion to the spleen, pancreas, or splenogastric ligament. 4)H0P0M0 and no bulky metastatic lymph nodes (bulky N2) by contrast-enhanced chest - abdominal computed tomography. 5) Neither Borrmann type 4 nor large (>8cm) type 3. 6)No esophageal invasion 7)Not a stump cancer of stomach 8) Expected R0 surgery 9) Body mass index (BMI) is less than 30 10)Aged between 20 and 85 years old 11)Eastern Cooperative Oncology Group performance status of 0 or 1. 12)No history of upper abdominal surgery or intestinal resection 13)No prior chemotherapy or radiotherapy for any malignancies except adjuvant chemotherapy after curative resection 14)Adequate organ functions defined as; i) WBC of 3,000/mm3 or more ii) Platelet count100,000/mm3 or more iii) T.Bil of 2.0 mg/dL or less iv) AST of 100 IU/L or less v) ALT of 100 IU/L or less vi) Creatinine of 1.5 mg/dL or less 15) Written informed consent
Exclusion criteria
Exclusion criteria: 1) Synchronous or metachronous (within 5 years) malignancies. 2) Infectious disease requiring systemic treatment. 3) Body temperature of 38 degrees Celsius or higher. 4) During pregnancy, within 28 days postpartum, or during lactation. 5) Severe mental disease. 6) Receiving continuous systemic corticosteroid or immunosuppressant treatment. 7) History of unstable angina pectoris within three weeks or myocardial infarction within six months before registration. 8) Poorly controlled valve disease, dilated or hypertrophic cardiomyopathy 9) HIV antibody positive 10) Interstitial pneumonia, pulmonary fibrosis, or severe emphysema based on chest CT
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of pancreatic fistula and/or abdominal abscess | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood loss, operation time, surgery-related death, overall complication, number of removed splenic hilar nodes, number of metastatic splenic hilar nodes, conversion to open surgery, conversion to splenectomy, relapse-free survival, overall survival | — |
Countries
Japan
Contacts
Public ContactTAKAHIRO KINOSHITA
JCOG1809 Coordinating Office Gastric Surgery Division, National Cancer Center East Hospital
Outcome results
None listed