Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area

Overview

Nowadays, while pursuing the eradication of tumor, how to maximize the preservation of normal anatomy and physiological functions of the stomach, reduce the surgical trauma caused by excessive debridement, and improve the quality of life of patients after surgery has become a more important concern in the treatment of early gastric cancer. This prospective multicenter randomized controlled clinical trial was designed to elucidate the oncologic safety of laparoscopic gastric preservation surgery compared to standard laparoscopic gastrectomy. The oncologic safety of laparoscopic gastric preservation surgery with anterior basal dissection (SBD) compared to standard laparoscopic gastrectomy. This trial is an investigator-initiated, multicenter, prospective, randomized, open, parallel-controlled with a non-inferiority design. Patients diagnosed as distal gastric cancer with clinical stage T1N0M0, with a lesion diameter of 3 cm or less were eligible to participate in this study. Patients will be randomized to either laparoscopic stomach-preserving surgery with SBD or standard surgery. The primary end-point is 3-year disease-free survival.

Eligibility

Inclusion Criteria：

1. single lesion detected by gastroscopy and clearly diagnosed histologically as gastric adenocarcinoma.
2. patients with gastric cancer with clinical stage T1N0M0 (based on the TNM stage of the 8th edition of AJCC) (T-stage assessed by ultrasound gastroscopy and N-stage and M-stage assessed by enhanced CT).
3. tumor length diameter less than 3 cm.
4. the lesion is located in the gastric sinus.
5. patient age greater than 20 years and less than 80 years.
6. ECOG score of 0 or 1.
7. The patient voluntarily participated in this clinical study.

Exclusion Criteria:

1. Patients with gastric cancer suitable for endoscopic treatment (differentiated gastric cancer with tumor length diameter less than 2 cm and located within the mucosa).
2. cardiopulmonary dysfunction that cannot tolerate laparotomy.
3. pyloric duct gastric cancer.
4. Previously undergone upper abdominal surgery.
5. other malignant tumors diagnosed within the previous five years.
6. Pregnant women.