ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

Stomach Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04056260
• Other study ID #: SDR-01
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Stomach Neoplasm
• Stomach Neoplasms

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