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.
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;
Allergy to ICG or iodine;
History of neck or thoracic surgery;
Patients requiring emergency surgery;
Tumors involving adjacent organs necessitating combined organ resection;
Parallel
ICG (Indocyanine Green)
DrugMinimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve.
Incidence of Postoperative Recurrent Laryngeal Nerve Injury
Definition and Significance: This is the core indicator for verifying the research hypothesis. It refers to the proportion of patients with objectively confirmed unilateral or bilateral RLN dysfunction after radical esophagectomy for esophageal cancer. The difference in this incidence between the ICG fluorescence-guided group and the conventional surgery (control) group will be compared. Assessment Method:Performed 7 days postoperatively (allowing for resolution of acute edema) by an independent otolaryngologist or speech-language pathologist blinded to the patient's group assignment, using fiberoptic laryngoscopy. Quantitative Indicators: Incidence=(Number of patients diagnosed with RLN palsy in each group / Total number of patients in that group) × 100%.
Rates of Temporary vs. Permanent RLN Injury
Definition: Distinguishes the nature of nerve injury. Temporary injury refers to nerve function that recovers within 6 months postoperatively; permanent injury refers to function that has not recovered after 6 months. Assessment Method: Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively. Quantitative Indicators: Calculate the proportion of temporary and permanent injuries both among total injuries and among the total patient population.
Incidence and Severity of Postoperative Voice Dysfunction
Definition: Assesses the functional consequences resulting from RLN injury. Assessment Method: (1) Voice Assessment: Use validated patient-reported questionnaires, such as the Voice Handicap Index-10 (VHI-10). 【Tips: The Voice Handicap Index-10 (VHI-10) has a score range of 0 to 40; a higher score indicates that voice handicap has a greater impact on daily life.】 Quantitative Indicators: (1) Proportion of patients with a VHI-10 total score ≥ 15 (indicating moderate or worse voice handicap) at a specified postoperative timepoint (e.g., 1 month).
Number of Lymph Nodes Dissected in the RLN Region
Definition: Verifies whether ICG-guided nerve preservation compromises the oncological radicality of lymphadenectomy. Assessment Method: Based on the final postoperative pathological report. Quantitative Indicators: (1) Total Number of lymph nodes harvested from the bilateral RLN regions (left + right) per group.
Incidence of Postoperative Pulmonary Complications
Definition: RLN injury predisposes to aspiration and pneumonia, making this a crucial clinical safety indicator. Assessment Method: Use standardized definitions, such as the Clavien-Dindo classification or the Esophagectomy Complications Consensus Group (ECCG) definitions, to record pneumonia, respiratory failure, ARDS, etc., occurring within 30 days postoperatively. Quantitative Indicators: Proportion of patients experiencing pulmonary complications of Grade II or higher.
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