ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

NCT ID: NCT04056260

Last Updated: 2020-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-20

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Stomach Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ICG injection

ICG 0.5mg/ml x 0.5ml x 4 sites

Group Type EXPERIMENTAL

ICG-NIR guided surgery

Intervention Type PROCEDURE

ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ICG-NIR guided surgery

ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Ho Seok Seo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ho Seok Seo

professor

Responsibility Role SPONSOR_INVESTIGATOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SDR-01

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

PG Versus TG for Advanced PGC
NCT06614439 COMPLETED NA