A Multicenter, RCT Study of the Clinical Efficacy of Robotic and Laparoscopic Gastrectomy in Neoadjuvant Gastric Cancer

Summary

To evaluate the clinical efficacy of robot radical Gastrectomy and laparoscopic radical Gastrectomy, patients with gastric adenocarcinoma (cT2N+M0 or cT3-4a/N+M0, phase II and III) undergoing neoadjuvant treatment were selected as subjects.

Eligibility

Inclusion Criteria:

1. 18 years old ≤ 75 years old male or female;
2. The primary gastric lesion was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, Signet ring cell carcinoma, poorly differentiated adenocarcinoma) by endoscopic biopsy histopathology;
3. Before neoadjuvant treatment, the preoperative clinical staging was confirmed to be II and III (cT2N+M0 or cT3-4a/N+M0) through gastroscopy/ultrasound gastroscopy, enhanced CT/MR, or diagnostic laparoscopic exploration (based on AJCC-8th TNM tumor staging);
4. 2-4 cycles of neoadjuvant therapy (chemotherapy+/- targeted/immunotherapy, simple chemotherapy);
5. After new adjuvant treatment, radical Gastrectomy is feasible after MDT discussion;
6. Preoperative ECOG physical condition score of 0/1 or Karst score ≥ 70%;
7. Preoperative ASA score I-III;
8. The expected survival period exceeds 6 months;
9. Willing and able to comply with the research protocol;
10. Sign a written informed consent form before enrollment and be fully aware of the right to withdraw from this study at any time.

Exclusion Criteria:

1. Pregnant or lactating women;
2. Suffering from serious mental illness;
3. History of upper abdominal surgery (excluding history of laparoscopic cholecystectomy);
4. History of gastric surgery (excluding ESD/EMR for gastric cancer);
5. Moderate to severe renal insufficiency;
6. Organ transplant recipients receiving immunosuppressive therapy;
7. Have a history of other malignant diseases within 5 years;
8. Have a history of unstable angina or myocardial infarction within 6 months;
9. Have a history of cerebral infarction or cerebral hemorrhage within 6 months;
10. Have a history of continuous systemic corticosteroid therapy within one month;
11. Simultaneous surgical treatment of other diseases is required (excluding laparoscopic cholecystectomy);
12. Gastric cancer comorbidities (bleeding, perforation, obstruction) requiring emergency surgery;
13. Lung function test FEV1\<50% of expected value;
14. The patient has participated or is currently participating in other clinical studies (within 6 months).

Conditions3

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