The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerv… (NCT07406815) | Clinical Trial Compass
Not Yet RecruitingPhase 3
The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy
China144 participantsStarted 2026-06-01
Plain-language summary
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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Postoperative Recurrent Laryngeal Nerve Injury
Timeframe: From enrollment to the end of surgery at 1 weeks