ICG-NIR Guided Lymph Node Dissection in Gastric Cancer | NCT04056260

Studies
ICG-NIR Guided Lymph Node Dissection in Gastric Cancer

NCT04056260

Sponsor

Ho Seok Seo

Status

Unknown status

Last Update Posted

Mar 20, 2020Actual

Enrollment

219Estimated

Phase

Not Applicable

Conditions

Stomach Neoplasm

Interventions

ICG-NIR guided surgery

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 20, 2020Estimated

Primary Completion Date

Aug 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Aug 11, 2019

First Submission Date that Met QC Criteria

Aug 13, 2019

First Posted Date

Aug 14, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2020

Last Update Posted Date

Mar 20, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

219Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ICG injection	Experimental	ICG 0.5mg/ml x 0.5ml x 4 sites	Procedure: ICG-NIR guided surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ICG-NIR guided surgery	Procedure	ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy	ICG injection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity and specificity	sensitivity and specificity of ICG-NIR guided lymph node dissection	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided