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

Not Applicable

• Conditions: Esophageal Cancer; Indocyanine Green
• Interventions: Drug: Indocyanine green solution

• Registration Number: NCT04615806
• Lead Sponsor: Fujian Medical University Union Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2020-09-22
• Study First Submitted: 2020-10-27
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-23
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-09-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIR-ICG	Indocyanine green solution	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.

Primary Outcome Measures

Name	Time	Method
False positive rate of lymph node dissection	1 week after operation	False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
False negative rate of lymph node dissection	1 week after operation	False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Accuracy rate of lymph node dissection	1 week after operation	Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
Sensitivity and specificity of lymph node dissection	1 week after operation	Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）

Secondary Outcome Measures

Name	Time	Method
The mapping of sentinel lymph nodes in esophageal cancer	1 week after operation	The mapping of sentinel lymph nodes in esophageal cancer

Trial Locations

Locations (1)

Fujian Medical University Union Hospital; 🇨🇳 Fuzhou, Fujian, China