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

NCT05160753 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 580

Last updated 2023-02-09

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Tongzhou District Hospital

    collaborator UNKNOWN

  • Haimen People's Hospital

    collaborator UNKNOWN

  • Dongtai People's Hospital

    collaborator UNKNOWN

  • Qidong City People's Hospital

    collaborator UNKNOWN

  • Rudong County Hospital of Traditional Chinese Medicine

    collaborator UNKNOWN

  • Affiliated Hospital of Nantong University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-10
Primary Completion
2024-06-30
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05160753 on ClinicalTrials.gov