A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients

July 17, 2023 updated by: Enrique F. Elli, Mayo Clinic

Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer

This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients ≥ 18 and ≤ 75 years of age.
  • Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy.
  • Clinical stage tumor T1-4a (cT1-4a), N -/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition.
  • No distant metastasis, no direct invasion of adjacent organs such as pancreas and spleen in preoperative exams.
  • American Society of Anesthesiology score (ASA) class I, II, or III.
  • Written informed consent.

Exclusion Criteria:

  • Patients ≤ 18 and ≥ 75 years of age.
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy).
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection.
  • History of allergy to iodine agents.
  • History of other malignant disease within past five years.
  • Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation.
  • Patients intraoperatively/postoperatively confirmed as T4b.
  • Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intervention
Injection of Indocyamine Green.
Drug: Indocyanine green
A one time injection of IDC prior to the day of scheduled surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive ICG fluorescence lymph nodes
Time Frame: Approximately 30-90 days after surgery
Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
Approximately 30-90 days after surgery
Disease positive lymph nodes
Time Frame: Approximately 30-90 days after surgery
Number of ICG positive lymph nodes that are also positive for disease
Approximately 30-90 days after surgery
Number of lymph nodes removed for each lymphatic station of gastrectomy
Time Frame: Approximately 30-90 days after surgery
Total number of lymph nodes removed for each lymphatic station of gastrectomy with NIR+ICG vs gastrectomy without NIR+ICG
Approximately 30-90 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Enrique F Elli, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2022

Primary Completion (Estimated)

January 1, 2022

Study Completion (Estimated)

August 10, 2022

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 15, 2020

First Posted (Actual)

October 19, 2020

Study Record Updates

Last Update Posted (Actual)

July 19, 2023

Last Update Submitted That Met QC Criteria

July 17, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-002747

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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