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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
144
Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve.
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
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%.
Time frame: From enrollment to the end of surgery at 1 weeks
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.
Time frame: Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively.
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).
Time frame: 1 month after surgery
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.
Time frame: 1 week after surgery.
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.
Time frame: 30 days after surgery.
Incidence and Severity of Postoperative Swallowing Dysfunction
Definition: Assesses the functional consequences resulting from RLN injury. Assessment Method: (1) Swallowing Assessment: Use the M.D. Anderson Dysphagia Inventory (MDADI). 【Tips: MDADI consists of 20 items and covers four domains: global, emotional, functional, and physical. It uses a 5-point Likert scale for scoring, and both the domain scores and the total score range from 0 to 100 points. A higher score indicates better swallowing function and quality of life.】 Quantitative Indicators: (1) Inter-group comparison of MDADI total scores or subscale scores.
Time frame: 30 days after surgery
Postoperative Hospital Stay Length
Definition: Reflects the overall recovery profile after surgery. Quantitative Indicators: (1) Postoperative Length of Stay (LOS): Number of days from surgery to meeting discharge criteria.
Time frame: 30 days after surgery.
Quality 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) Metastasis Positive Rate in this region (number of metastatic lymph nodes / total number harvested).
Time frame: 1 week after surgery.
Postoperative Readmission Rate.
Definition: Reflects the overall recovery profile after surgery. Quantitative Indicators: (1) 30-day Unplanned Readmission Rate: Particularly the rate of readmission due to pneumonia, dysphagia, or hoarseness-related issues.
Time frame: 30 days after surgery.
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