NCT07406815Not yet recruitingPhase 3
The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy
The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy：A Prospective Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 12 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 144 (estimated)
- First submitted
- 26 Nov 2024
- Start date
- 1 Jun 2026
- Primary completion date
- 1 Jul 2026
- Lead sponsor
- Fujian Medical University Union Hospital
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07406815
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 144
- From 1 Jun 2026 to the primary completion date, 1 Jul 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients requiring emergency surgery;
- Tumors involving adjacent organs necessitating combined organ resection;
- Participation in or having participated in other clinical trials within 4 weeks prior to selection;
- Patients who, after assessment or intraoperative exploration, cannot undergo the planned surgery;
- Patients with concomitant non-neoplastic conditions that prevent them from continuing with the study protocol;
Other illness
- Allergy to ICG or iodine;
- History of neck or thoracic surgery;
- History of severe mental illness;
- Patients with other conditions deemed unsuitable for participation by the investigator;
Other
- Patients with tumor recurrence or distant metastasis;
- Pregnant or lactating women;
- Intraoperative conversion to open thoracotomy.
- Patients who voluntarily withdraw from the study;
- Patients who, after enrollment in the study, are unable to complete it due to other reasons.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fujian Medical University Union Hospital Coordinator of this site? Confirm its status | Fuzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.