ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

Overview

As the survival rate of patients with gastric cancer has increased, there has been a growing interest in interventions that improve postoperative quality of life. Therefore minimally invasive surgery or endoscopic resection has been performed much more frequently. However, adequate lymph node dissection is important as well. The aim of the study is to identify the feasibility of indocyanine green – near infra-red (ICG-NIR) guided sentinel lymph node dissection for the treatment of gastric cancer.

Full Title of Study: “Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 31, 2020

Interventions

  • Procedure: ICG-NIR guided surgery
    • ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy

Arms, Groups and Cohorts

  • Experimental: ICG injection
    • ICG 0.5mg/ml x 0.5ml x 4 sites

Clinical Trial Outcome Measures

Primary Measures

  • sensitivity and specificity
    • Time Frame: 1 month
    • sensitivity and specificity of ICG-NIR guided lymph node dissection

Participating in This Clinical Trial

Inclusion Criteria

  • dignosed gastric adenocarcinoma
  • tumor: size 4cm or smaller
  • depth of invasion: mucosa, submucosa, proper muscle
  • candidates of laparoscopic radical gastrectomy
  • informed consent

Exclusion Criteria

  • metachronous malignancy
  • number of tumors: 2 or more
  • remnant gastric cancer
  • indication for endoscopic resection
  • history of chemotherapy or radiation therapy
  • pregnancy
  • allergy to ICG
  • metastatic gastric cancer

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Ho Seok Seo
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Ho Seok Seo, professor – Seoul St. Mary’s Hospital

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.