The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy
Starting soon · Phase 3
Conditions studied: Esophageal Cancer, Recurrent Laryngeal Nerve, ICG (Indocyanine Green), Lymph Node Dissection
In brief
The goal of this clinical trial is to learn whether the application of indocyanine green near-infrared imaging system can accurately locate the recurrent laryngeal nerve (RLN) during lymph node dissection in esophageal cancer radical surgery, thereby reducing the risk of RLN injury. The main questions it aims to answer are: 1. Can preoperative intravenous administration of indocyanine green enable visualization of the RLN; 2. Does performing RLN dissection guided by near-infrared imaging system reduce the probability of RLN injury, leading to better clearance of RLN lymph nodes and improved RLN protection rates? Researchers will compare whether indocyanine green was intravenously administered preoperatively to assess intraoperative RLN visualization. Participants in the study group will receive intravenous indocyanine green at a dose of 5mg/kg 24 hours before surgery. All patients will be monitored for RLN injury-related complications postoperatively, and RLN injury status will be objectively assessed via laryngoscopy one week post-operation.
Key facts
- Study ID
- NCT07406815
- Run by
- Fujian Medical University Union Hospital
- People needed
- 144
- Starts
- 2026-06-01
- Expected to finish
- 2028-06-01
- Last updated by the study team
- 2026-02-12
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age between 18 and 75 years at the time of diagnosis (excluding 18 and 75);
- Preoperative biopsy pathology confirming esophageal cancer;
- Undergoing elective thoracoscopic esophageal cancer radical surgery with intraoperative anastomosis;
- Tolerable heart, lung, liver, and kidney function for surgery;
- Patients and their families are able to understand and willing to participate in this clinical study, and have signed an informed consent form.
You may not qualify if…
- Allergy to ICG or iodine;
- History of neck or thoracic surgery;
- Patients requiring emergency surgery;
- Tumors involving adjacent organs necessitating combined organ resection;
- Patients with tumor recurrence or distant metastasis;
- Participation in or having participated in other clinical trials within 4 weeks prior to selection;
- History of severe mental illness;
- Pregnant or lactating women;
- Patients with other conditions deemed unsuitable for participation by the investigator;
- Intraoperative conversion to open thoracotomy.
- Patients who, after assessment or intraoperative exploration, cannot undergo the planned surgery;
- Patients who voluntarily withdraw from the study;
- Patients with concomitant non-neoplastic conditions that prevent them from continuing with the study protocol;
- Patients who, after enrollment in the study, are unable to complete it due to other reasons.
Where it is running
- Fujian Medical University Union Hospital — Fuzhou, Fujian, China
Full record on ClinicalTrials.gov
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