Gastric cancer
Conditions
Interventions
Group 2:Open surgery
Sponsors
Zhongshan Hospital Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years; 2. Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D2 lymphadenectomy (also apply to multiple primary cancers); 3. Primary lesion is pathologically diagnosed as gastric adenocarcinoma, such as papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, poorly cohesive carcinoma (including signet ring cell carcinoma and other variants), and mixed adenocarcinoma; 4. Clinical stage cT2-4aN0-3M0 (According to AJCC-7th TNM staging system); 5. Life expectancy exceeds 6 months; 6. No invasion to Z-line; 7. BMI (Body Mass Index) < 30 kg/m2; 8. No history of upper abdominal surgery (except for laparoscopic cholecystectomy); 9. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.; 10. Preoperative performance status (ECOGEastern Cooperative Oncology Group) of 0 or 1; 11. Preoperative ASA (American Society of Anesthesiologists) scoring: I-III; 12. Sufficient organ functions; 13. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter >= 3.0cm); 2. Women during pregnancy or breast-feeding; 3. Synchronous or metachronous (within 5 years) malignancies; 4. Body temperature >=38 degree C before surgery or infectious disease with a systemic therapy indicated; 5. Severe mental disease; 6. Severe respiratory disease; 7. Severe hepatic and renal dysfunction; 8. Unstable angina pectoris or history of myocardial infarction within 6 months; 9. History of cerebral infarction or cerebral hemorrhage within 6 months; 10. Continuous systemic steroid therapy within 1 month (except for topical use); 11. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery; 12. Patients are participating or have participated in another clinical trial (within 6 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year overall survival rate;3-year disease free survival rate;Morbidity and mortality rates;3-year recurrence pattern;Postoperative recovery course; | — |
Countries
China
Contacts
Public ContactYihong Sun
Zhongshan Hospital Fudan University
Outcome results
None listed