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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04056260
Other study ID # SDR-01
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 20, 2020
Est. completion date December 31, 2020

Study information

Verified date March 2020
Source Seoul St. Mary's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 219
Est. completion date December 31, 2020
Est. primary completion date August 31, 2020
Accepts healthy volunteers No
Gender All
Age group 20 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ho Seok Seo

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity and specificity sensitivity and specificity of ICG-NIR guided lymph node dissection 1 month
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