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

February 7, 2023 updated by: Qinsheng Mao, Affiliated Hospital of Nantong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

580

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Nantong, China
        • Recruiting
        • Affiliated Hospital of Nantong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
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.
ACTIVE_COMPARATOR: Patients in the control group will undergo standard laparoscopic gastrectomy
Patients in the control group will undergo standard laparoscopic gastrectomy (laparoscopic distal gastrectomy with simultaneous D1+ lymph node dissection).
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-free survival (DFS) at three years
Time Frame: 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.
three years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Affiliated Hospital of Nantong University

Collaborators

Tongzhou District Hospital
Haimen People's Hospital
Dongtai People's Hospital
Qidong City People's Hospital
Rudong County Hospital of Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 10, 2022

Primary Completion (ANTICIPATED)

June 1, 2024

Study Completion (ANTICIPATED)

December 1, 2024

Study Registration Dates

First Submitted

December 3, 2021

First Submitted That Met QC Criteria

December 3, 2021

First Posted (ACTUAL)

December 16, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LGFPS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastric Cancer Stage I

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Algeria

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe