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

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.

Surgical treatment is currently the best and preferred method for treating esophageal cancer. Esophagectomy is a highly specialized surgery with a high incidence of complications, among which recurrent laryngeal nerve (RLN) paralysis is one of the most common postoperative complications, severely affecting postoperative quality of life. This study adopts a single-center, prospective, open, controlled, non-inferiority validation design. It focuses on patients with esophageal cancer scheduled for esophageal cancer radical surgery. The study aims to include 144 patients with esophageal cancer, randomized in a 1:1 ratio into two groups: the experimental group receiving indocyanine green (ICG) injection and the control group not receiving ICG injection. A comparison will be made between the two groups regarding laryngeal physiological changes one week post-operation. The study will observe the occurrence rate of symptoms related to RLN injury post-surgery, the duration of RLN dissection, and other relevant indicators. The goal is to explore whether the application of NIR-ICG imaging systems can accurately locate the RLN during lymph node dissection in esophageal cancer radical surgery, thereby reducing the risk of RLN injury.

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.