NCT04056260

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
219

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 14, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

March 20, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 20, 2020

Status Verified

March 1, 2020

Enrollment Period

5 months

First QC Date

August 11, 2019

Last Update Submit

March 19, 2020

Conditions

Stomach Neoplasm

Outcome Measures

Primary Outcomes (1)

  • sensitivity and specificity

    sensitivity and specificity of ICG-NIR guided lymph node dissection

    1 month

Study Arms (1)

ICG injection

EXPERIMENTAL

ICG 0.5mg/ml x 0.5ml x 4 sites

Procedure: ICG-NIR guided surgery

Interventions

ICG-NIR guided surgeryPROCEDURE

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

ICG injection

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • dignosed gastric adenocarcinoma
  • tumor: size 4cm or smaller
  • depth of invasion: mucosa, submucosa, proper muscle
  • candidates of laparoscopic radical gastrectomy
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 11, 2019

First Posted

August 14, 2019

Study Start

March 20, 2020

Primary Completion

August 31, 2020

Study Completion

December 31, 2020

Last Updated

March 20, 2020

Record last verified: 2020-03