Gastric cancer
Conditions
Interventions
Group A:Minimally invasive surgery (robotic, complete laparoscopic, laparoscopic assisted) Proximal subtotal gastrectomy group
Group B:Minimally invasive (robotic, total laparoscopic, laparoscopic assisted) total gastrectomy group
Sponsors
Department of Gastric Oncology, Tianjin Medical University Cancer Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 to 75 years; 2. ECOG score 0-2; 3. Histologically diagnosed as gastric adenocarcinoma; 4. Perform clinical staging based on enhanced CT/MRI examination (combined with ultrasound gastroscopy and diagnostic laparoscopic exploration when necessary). The stages are c stage II and III (T1-4a/N+ M0, T3–4a/N- M0, AJCC section The eighth version of cTNM staging of gastric cancer), the maximum diameter of the tumor is less than or equal to 4cm; 5. The length of the esophagus involved is less than 3cm; 6. The research center and the surgeon can complete radical D2 lymph node dissection (the number of lymph nodes checked must be at least 15 to ensure the quality of the operation) surgery, R0 resection; 7. Physical condition and organ function allow for larger abdominal surgery; 8. It has sufficient organ and bone marrow functions, defined as follows: (1) Blood routine: absolute neutrophil count (ANC)>=1.5x10^9/L; platelet count (PLT)>=100x10^9/L; hemoglobin content (HGB)>=9.0 g/dL. (2) Liver function: Patients without liver metastasis require serum total bilirubin (TBIL) =50 mL/min (calculated by Cockcroft/Gault formula): 1) Female: Ccr= (140-years old) x weight (kg) x 0.85, 72 x serum creatinine (mg/dL); 2) Male: Ccr= (140-years old) x weight (kg) x 1.00, 72 x serum creatinine (mg/dL); (4) The coagulation function is adequate, defined as the international normalized ratio (INR) or prothrombin time (PT) =50%; 10. Agree and be able to comply with the plan during the research period; 11. Provide written informed consent before entering the study screening, and the patient has understood that he can withdraw from the study at any time during the study without any loss; agree to provide blood and histological specimens.
Exclusion criteria
Exclusion criteria: 1. Pregnant or lactating women; 2. Received previous anti-tumor therapy, including chemotherapy, radiotherapy, targeted therapy or immunotherapy, etc.; 3. Suffered from other malignant tumors in the past 5 years (except basal cell or squamous cell carcinoma, superficial bladder cancer, cervical cancer in situ or breast cancer); 4. Uncontrollable pleural effusion, pericardial effusion or ascites; 5. Those with a history of uncontrolled epilepsy, central nervous system disease or mental disorder; 6. Pulmonary function test FEV1= Grade II, uncontrolled arrhythmia, and myocardial infarction; 8. Complicated with upper gastrointestinal obstruction/bleeding or abnormal digestive function or malabsorption syndrome; 9. Concurrent serious uncontrolled concurrent infection or other serious uncontrolled concomitant disease; 10. Previous upper abdominal surgery (except for the history of laparoscopic cholecystectomy); 11. Use steroids or other systemic immunosuppressive therapies 14 days before enrollment; 12. Patients who received study drug treatment within 4 weeks before enrollment (participated in other clinical trials); 13. There is a history of cerebral infarction or cerebral hemorrhage in the last 6 months; 14. History of primary immunodeficiency, history of known allogeneic organ transplantation and history of allogeneic hematopoietic stem cell transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early postoperative complications (30 days), lymph node metastasis rates in zones 3B, 5, 19, and 20; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3-year relapse-free survival rate; | — |
Countries
China
Contacts
Public ContactDing Xuewei
Tianjin Medical University Cancer Hospital
Outcome results
None listed