The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy

January 23, 2022 updated by: Fujian Medical University Union Hospital

The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy

Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

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

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age and gender: 18-75 years old, male and female unlimited;
  2. Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
  3. Preoperative combination with neoadjuvant chemoradiotherapy;
  4. Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
  5. Heart, lung, liver and kidney functions can tolerate operation;
  6. Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.

Exclusion Criteria:

  1. Allergic to ICG or iodine;
  2. Patients with a history of chest surgery or thoracic lymph node dissection;
  3. Patients needing emergency surgery;
  4. Patients whose tumors involve neighboring organs and need to be removed by combining organs;
  5. Patients with tumor recurrence or distant metastasis;
  6. Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
  7. A history of serious mental illness;
  8. Pregnant or lactating women;
  9. Patients with other conditions considered by the researcher should not participate in the study.

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NIR-ICG
After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml.
Drug: Indocyanine green solution
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
Other Names:
  • Indocyanine Green for Injection
No Intervention: Control
This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy rate of lymph node dissection
Time Frame: 1 week after operation
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
1 week after operation
False positive rate of lymph node dissection
Time Frame: 1 week after operation
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
1 week after operation
False negative rate of lymph node dissection
Time Frame: 1 week after operation
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
1 week after operation
Sensitivity and specificity of lymph node dissection
Time Frame: 1 week after operation
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
1 week after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The mapping of sentinel lymph nodes in esophageal cancer
Time Frame: 1 week after operation
The mapping of sentinel lymph nodes in esophageal cancer
1 week after operation

Collaborators and Investigators

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

Sponsor

Fujian Medical University Union Hospital

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.

General Publications

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 (Actual)

September 22, 2020

Primary Completion (Anticipated)

September 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

October 27, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

January 25, 2022

Last Update Submitted That Met QC Criteria

January 23, 2022

Last Verified

January 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICG-NIR UNION

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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