Back to resultsICG-NIR Guided Lymph Node Dissection in Gastric Cancer
Primary Purpose
Stomach Neoplasm
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ICG-NIR guided surgery
Sponsored by
About this trial
This is an interventional treatment trial for Stomach Neoplasm
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ICG injection
Arm Description
ICG 0.5mg/ml x 0.5ml x 4 sites
Outcomes
Primary Outcome Measures
sensitivity and specificity
sensitivity and specificity of ICG-NIR guided lymph node dissection
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04056260
Brief Title
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
Official Title
Oncologic Safety of Sentinel Lymph Node-guided Lymph Node Dissection Using ICG-NIR Laparoscopy in Gastric Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 20, 2020 (Anticipated)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ho Seok Seo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stomach Neoplasm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
219 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICG injection
Arm Type
Experimental
Arm Description
ICG 0.5mg/ml x 0.5ml x 4 sites
Intervention Type
Procedure
Intervention Name(s)
ICG-NIR guided surgery
Intervention Description
ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy
Primary Outcome Measure Information:
Title
sensitivity and specificity
Description
sensitivity and specificity of ICG-NIR guided lymph node dissection
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Learn more about this trial
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer
We'll reach out to this number within 24 hrs