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

• Sponsor: Fujian Medical University Union Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04615806
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 36.2
• Patients Per Site Per Month: 1.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Esophageal Cancer; Indocyanine Green	Drug: Indocyanine green solution	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
• Actual Study Start Date: Sep 22, 2020
• Anticipated Primary Completion Date: Sep 30, 2022
• Anticipated Study Completion Date: Sep 30, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Accuracy rate of lymph node dissection [1 week after operation]

   Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）

2. False positive rate of lymph node dissection [1 week after operation]

   False positive rate of lymph node dissectionof each arm（according to postoperative pathology）

3. 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）

4. 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

1. The mapping of sentinel lymph nodes in esophageal cancer [1 week after operation]

   The mapping of sentinel lymph nodes in esophageal cancer

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fujian Medical University Union Hospital	Fuzhou	Fujian	China	350001

Sponsors and Collaborators

• Fujian Medical University Union Hospital

Investigators

• Study Director: Chun Chen, MD, Fujian Medical University Union Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fujian Medical University Union Hospital
• ClinicalTrials.gov Identifier: NCT04615806
• Other Study ID Numbers: ICG-NIR UNION
• First Posted: Nov 4, 2020
• Last Update Posted: Jan 25, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fujian Medical University Union Hospital: Esophageal Cancer; Indocyanine Green; the lymph node markers
• Additional relevant MeSH terms: Esophageal Neoplasms

Study Results

No Results Posted as of Jan 25, 2022