The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy

Sponsor
Fujian Medical University Union Hospital
Study ID
NCT07406815
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Esophageal Cancer
  • ICG (Indocyanine Green)
  • Lymph Node Dissection
  • Recurrent Laryngeal Nerve

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ICG (Indocyanine Green) — DRUG
    Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve.

Study Details

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.

Key Dates

Start date
Jun 1, 2026
Status verified
Dec 2025
Primary completion
Jul 1, 2026
Completion
Jun 1, 2028

Study Design

Enrollment
144 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: (ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualization
  • No Intervention: (Control group) receiving VATS without near-infrared-indocyanine green fluorescence for RLN visualiz

Primary Outcome Measure

Incidence of Postoperative Recurrent Laryngeal Nerve Injury [ Time Frame: From enrollment to the end of surgery at 1 weeks ]

Central Contacts

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