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

Not Applicable

Recruiting

• Conditions: Gastric Cancer Stage I
• Interventions: Procedure: Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area

• Registration Number: NCT05160753
• Lead Sponsor: Affiliated Hospital of Nantong University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-12-03
• Study First Submitted QC: 2021-12-03
• Study First Posted: 2021-12-16
• Study Start: 2022-01-10
• Status Verified: 2022-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-06
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 580

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
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	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.
Patients in the control group will undergo standard laparoscopic gastrectomy	Laparoscopic gastric function preserving surgery combined with resection of the anterior lymphatic drainage area	Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).

Primary Outcome Measures

Name	Time	Method
Disease-free survival (DFS) at three years	three years	The criteria for DFS events in this study were as follows: recurrence of the primary tumor at the incisional margin or anastomosis, heterochronic metastasis in the remnant stomach, histologically or imaging confirmed intraperitoneal recurrence, lymph node metastasis, distant metastasis, new malignancy in other organs, and other causes of death.

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, China