ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

March 19, 2020 updated by: Ho Seok Seo

Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

219

Phase

  • Not Applicable

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:

  • 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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ICG injection
ICG 0.5mg/ml x 0.5ml x 4 sites
Procedure: ICG-NIR guided surgery
ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Ho Seok Seo

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 (Anticipated)

March 20, 2020

Primary Completion (Anticipated)

August 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

August 11, 2019

First Submitted That Met QC Criteria

August 13, 2019

First Posted (Actual)

August 14, 2019

Study Record Updates

Last Update Posted (Actual)

March 20, 2020

Last Update Submitted That Met QC Criteria

March 19, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDR-01

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.

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