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

NCT04615806 | Unknown

• 1 other identifier: ICG-NIR UNION
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Cancer; Indocyanine Green

Keywords

Esophageal Cancer; Indocyanine Green; the lymph node markers

Outcome Measures

Primary Outcomes (4)

• Accuracy rate of lymph node dissection

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

  1 week after operation

• False positive rate of lymph node dissection

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

  1 week after operation

• 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

• 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 Outcomes (1)

• The mapping of sentinel lymph nodes in esophageal cancer

  1 week after operation

Study Arms (2)

NIR-ICG

EXPERIMENTAL

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

Control

NO INTERVENTION

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

Interventions

Indocyanine green solution DRUG

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

Also known as: Indocyanine Green for Injection

NIR-ICG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

Related Publications (2)

• Du J, Zeng T, Zhang S, Chen M, Huang G, Xu C, Xu G, Ni C, Hong R, Zheng W, Chen C, Zheng B. Comparison of indocyanine green-near-infrared fluorescence guided and traditional mediastinal lymphadenectomy during radical esophagectomy: A randomized controlled trial. Surgery. 2024 Feb;175(2):347-352. doi: 10.1016/j.surg.2023.10.007. Epub 2023 Nov 26.

  PMID: 38012899 DERIVED

• Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29.

  PMID: 35770339 DERIVED

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Chun Chen, MD

  Fujian Medical University Union Hospital

  STUDY DIRECTOR

Central Study Contacts

Bin Zheng, MD

CONTACT

13023806690; Dujt1220@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2020
• First Posted: November 4, 2020
• Study Start: September 22, 2020
• Primary Completion: September 30, 2022
• Study Completion: September 30, 2023
• Last Updated: January 25, 2022

Record last verified: 2022-01

Locations

CN (1)