ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

Ho Seok Seo

Status: Unknown

Conditions: Stomach Neoplasm

Treatments: Procedure: ICG-NIR guided surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT04056260

SDR-01

Details and patient eligibility

About

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.

Enrollment: 219 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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219 participants in 1 patient group

ICG injection

Experimental group

Description:

ICG 0.5mg/ml x 0.5ml x 4 sites

Treatment:

Procedure: ICG-NIR guided surgery