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

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04615806
• Other study ID #: ICG-NIR UNION
• Status: Recruiting
• Phase: N/A
• Start date: September 22, 2020
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2022
• Source: Fujian Medical University Union Hospital
• Contact: Bin Zheng, MD
• Phone: 13023806690
• Email: Dujt1220[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Indocyanine Green

Intervention

Drug:
• Indocyanine green solution
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University Union Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy rate of lymph node dissection	Accuracy rate of lymph node dissection of each arm(according to postoperative pathology)	1 week after operation
Primary	False positive rate of lymph node dissection	False positive rate of lymph node dissectionof each arm(according to postoperative pathology)	1 week after operation
Primary	False negative rate of lymph node dissection	False negative rate of lymph node dissection of each arm(according to postoperative pathology)	1 week after operation
Primary	Sensitivity and specificity of lymph node dissection	Sensitivity and specificity of lymph node dissection of each arm(according to postoperative pathology)	1 week after operation
Secondary	The mapping of sentinel lymph nodes in esophageal cancer	The mapping of sentinel lymph nodes in esophageal cancer	1 week after operation