The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy：A Prospective Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Status
- Not yet recruiting
- Enrollment
- 144
- Locations
- 1
- Primary Endpoint
- Incidence of Postoperative Recurrent Laryngeal Nerve Injury
Overview
Brief 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:
- Can preoperative intravenous administration of indocyanine green enable visualization of the RLN;
- 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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
(ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualization
Intervention: ICG (Indocyanine Green) (Drug)
(Control group) receiving VATS without near-infrared-indocyanine green fluorescence for RLN visualiz
Outcomes
Primary Outcomes
Incidence of Postoperative Recurrent Laryngeal Nerve Injury
Time Frame: From enrollment to the end of surgery at 1 weeks
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%.
Secondary Outcomes
- Rates of Temporary vs. Permanent RLN Injury(Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively.)
- Incidence and Severity of Postoperative Voice Dysfunction(1 month after surgery)
- Number of Lymph Nodes Dissected in the RLN Region(1 week after surgery.)
- Incidence of Postoperative Pulmonary Complications(30 days after surgery.)
- Incidence and Severity of Postoperative Swallowing Dysfunction(30 days after surgery)
- Postoperative Hospital Stay Length(30 days after surgery.)
- Quality of Lymph Nodes Dissected in the RLN Region(1 week after surgery.)
- Postoperative Readmission Rate.(30 days after surgery.)