Study On Safety Of Laparoscopic Total Gastrectomy For Clinical Stage I Gastric Cancer (CLASS02-01)

This is an interventional treatment trial for Gastric Cancer focused on measuring Gastric cancer, Laparoscopic total gastrectomy, Open total gastrectomy Read More

Inclusion Criteria:

1. Aged 18-75 years；
2. 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;
3. Clinical stage IA (T1N0M0) or IB (T1N1M0, T2N0M0) (According to AJCC-7th TNM staging system);
4. Tumor located in the upper or middle third of the stomach, and curative resection is expected to be achievable by total gastrectomy with D1+/D2-10 lymphadenectomy (also apply to multiple primary cancers);
5. No invasion to Z-line;
6. BMI (Body Mass Index) < 30 kg/m2;
7. No history of upper abdominal surgery (except for laparoscopic cholecystectomy);
8. No prior treatment of chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.;
9. No enlargement of splenic hilar lymph nodes;
10. Preoperative performance status (ECOG，Eastern 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:

1. Preoperative examinations indicate that the stage of the disease is stage II/III/IV;
2. Preoperative examination indicate enlargement of perigastric or retroperitoneal lymph nodes (min diameter≥1.0cm);
3. Women during pregnancy or breast-feeding;
4. Synchronous or metachronous (within 5 years) malignancies;
5. Body temperature ≥ 38℃ before surgery or infectious disease with a systemic therapy indicated;
6. Severe mental disease;
7. Severe respiratory disease;
8. Severe hepatic and renal dysfunction;
9. Unstable angina pectoris or history of myocardial infarction within 6 months;
10. History of cerebral infarction or cerebral hemorrhage within 6 months;
11. Continuous systemic steroid therapy within 1 month (except for topical use);
12. Gastric cancer complications (bleeding, perforation, obstruction) that requiring emergency surgery;
13. Patients are participating or have participated in another clinical trial (within 6 months).