RCT on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection

  • STATUS
    Recruiting
  • participants needed
    266
  • sponsor
    Fujian Medical University
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Updated on 16 February 2024
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cancer
metastasis
adenocarcinoma
carcinoma
gastric cancer
gastric adenocarcinoma
lymphadenectomy
endoscopic biopsy
mucinous adenocarcinoma
tubular
signet ring cell carcinoma
papillary adenocarcinoma

Summary

The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymph node dissection of gastric cancer was different in tracing lymph nodes of gastric cancer. The patients with gastric adenocarcinoma (cT1-4a, Nmuramel +, M0) were studied.

Description

In recent years, with the successful application of ICG fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospect and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard.Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 radical resection of gastric cancer.The investigator first carried out this study in the world to evaluate the lymph node acquisition and perioperative safety of gastric cancer patients who received submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, in order to promote the standardized development of ICG near infrared imaging in laparoscopic radical gastrectomy.

Details
Condition Indocyanine Green, Gastropathy, Gastric Cancer, Gastric Cancer, Injection Site
Age 18years - 75years
Treatment Subserosa injection of indocyanine green, submucosal injection of indocyanine green
Clinical Study IdentifierNCT04219332
SponsorFujian Medical University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

Age from over 18 to under 75 years
Endoscopic biopsy of gastric primary lesions was diagnosed as gastric adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma, mucinous adenocarcinoma, signet ring cell carcinoma, and poorly differentiated adenocarcinoma)
The preoperative clinical staging was cT1-4a, N0-3, and M0, according to the AJCC-7th TNM tumor staging
No distant metastasis was detected before the operation, and the tumor did not directly invade the pancreas, spleen and other nearby organs
Preoperative ECOG physical status score 0-1
Preoperative ASA score I-III
Informed consent of the patient

Exclusion Criteria

Pregnant or lactating women
Suffering from severe mental illness
History of upper abdominal surgery (except laparoscopic cholecystectomy)
History of gastric surgery (including ESD / EMR for gastric cancer)
Preoperative imaging examination showed regional fusion of enlarged lymph nodes (maximum diameter 3cm)
History of other malignant diseases within 5 years
Neoadjuvant treatment has been implemented
Unstable angina pectoris within 6 months or history of myocardial infarction
History of cerebral infarction or cerebral hemorrhage within 6 months
History of continuous systemic corticosteroid treatment within 1 month
Concurrent surgery for other diseases is required
Gastric cancer complications (bleeding , perforation, obstruction) and need emergency surgery
FEV1 of pulmonary function test <50% of the expected value
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