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

  • STATUS
    Recruiting
  • participants needed
    266
  • sponsor
    Fujian Medical University
Updated on 19 February 2024
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 on19 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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

Study AnnotationsStudy Notes

Notes added here are public and can be viewed by anyone. Notes added here are only available to you and those who you share with.

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.