NCT05160753

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

Laparoscopic Gastric Function Preserving Surgery Combined With Resection of the Anterior Lymphatic Drainage Area. Comparison of Laparoscopic Standard Radical Gastric Cancer Surgery for Early Distal Gastric Cancer Multicenter, Prospective, Randomized, Open, Parallel-controlled, Non-inferiority Efficacy Clinical Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 580 (estimated)
• Sponsor: Affiliated Hospital of Nantong University · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Gastric Cancer Stage I

Interventions

Type	Name	Description
PROCEDURE	Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area	A 4mL volume of double tracer is injected into the submucosa of the four quadrants of the primary tumor by intraoperative gastroscopic method., 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.If all collected anterior lymph nodes are negative, laparoscopic gastric function preserving surgery will be performed.

Timeline

• Start date: 2022-01-10
• Primary completion: 2024-06-01
• Completion: 2024-12-01
• First posted: 2021-12-16
• Last updated: 2023-02-09

Locations

1 site across 1 country: China