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

Affiliated Hospital of Nantong University

Status: Enrolling

Conditions: Gastric Cancer Stage I

Treatments: Procedure: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

Study type: Interventional

Funder types: Other

Identifiers

NCT05160753

LGFPS

Details and patient eligibility

About

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.

Enrollment: 580 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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580 participants in 2 patient groups

gastric function preserving surgery combined with resection of the anterior lymphatic drainage area.

Experimental group

Description:

1. Steps of sentinel lymph node dissection Indocyanine green (ICG) tracing of anterior lymph nodes. ICG injection: A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method. 0.5 mL was injected at each site, and 15 minutes after gastroscopic tracer injection, the green anterior lymph nodes were carefully dissected and removed from the surgical area and evaluated for lymph node metastasis by parallel intraoperative freezing. 2. Intraoperative and postoperative pathological examination Intraoperative histological examination of lymph nodes collected from the anterior lymph node pool was performed, If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed. After surgery, anterior lymph nodes that proved to be tumor-free on intraoperative frozen section examination were reevaluated.

Treatment:

Procedure: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

Patients in the control group will undergo standard laparoscopic gastrectomy

Active Comparator group

Description:

Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).

Treatment:

Procedure: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area