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NOT YET RECRUITING
NCT07406815
PHASE3

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

View on ClinicalTrials.gov

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: 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.

Official title: The Value of Near-Infrared Fluorescence Imaging in the Protection of the Recurrent Laryngeal Nerve During Minimally Invasive Esophagectomy:A Prospective Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

144

Start Date

2026-06-01

Completion Date

2028-06-01

Last Updated

2026-02-12

Healthy Volunteers

No

Interventions

DRUG

ICG (Indocyanine Green)

Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the recurrent laryngeal nerve.

Locations (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China