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

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-22

Study Completion Date

2023-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Esophageal Cancer Indocyanine Green

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Indocyanine green solution

Intervention Type DRUG

ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.

Control

This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Indocyanine green solution

ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.

Intervention Type DRUG

Other Intervention Names

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Indocyanine Green for Injection

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No