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

NCT07406815 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: NERV-ICG
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

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:

1. 1.Can preoperative intravenous administration of indocyanine green enable visualization of the RLN;
2. 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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%.

  From enrollment to the end of surgery at 1 weeks

Secondary Outcomes (8)

• 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

Study Arms (2)

(ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualization

EXPERIMENTAL

Drug: ICG (Indocyanine Green)

(Control group) receiving VATS without near-infrared-indocyanine green fluorescence for RLN visualiz

NO INTERVENTION

Interventions

ICG (Indocyanine Green) DRUG

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

(ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualization

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patients who, after assessment or intraoperative exploration, cannot undergo the planned surgery;
• Patients who voluntarily withdraw from the study;
• Patients with concomitant non-neoplastic conditions that prevent them from continuing with the study protocol;
• Patients who, after enrollment in the study, are unable to complete it due to other reasons.

Sponsors & Collaborators

• Fujian Medical University Union Hospital: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Related Publications (5)

• Taniyama Y, Miyata G, Kamei T, Nakano T, Abe S, Katsura K, Sakurai T, Teshima J, Hikage M, Ohuchi N. Complications following recurrent laryngeal nerve lymph node dissection in oesophageal cancer surgery. Interact Cardiovasc Thorac Surg. 2015 Jan;20(1):41-6. doi: 10.1093/icvts/ivu336. Epub 2014 Oct 13.

  PMID: 25312996 RESULT

• Bundred JR, Hollis AC, Evans R, Hodson J, Whiting JL, Griffiths EA. Impact of postoperative complications on survival after oesophagectomy for oesophageal cancer. BJS Open. 2020 Jun;4(3):405-415. doi: 10.1002/bjs5.50264. Epub 2020 Feb 17.

  PMID: 32064788 RESULT

• Gelpke H, Grieder F, Decurtins M, Cadosch D. Recurrent laryngeal nerve monitoring during esophagectomy and mediastinal lymph node dissection. World J Surg. 2010 Oct;34(10):2379-82. doi: 10.1007/s00268-010-0692-0.

  PMID: 20563722 RESULT

• Hikage M, Kamei T, Nakano T, Abe S, Katsura K, Taniyama Y, Sakurai T, Teshima J, Ito S, Niizuma N, Okamoto H, Fukutomi T, Yamada M, Maruyama S, Ohuchi N. Impact of routine recurrent laryngeal nerve monitoring in prone esophagectomy with mediastinal lymph node dissection. Surg Endosc. 2017 Jul;31(7):2986-2996. doi: 10.1007/s00464-016-5317-8. Epub 2016 Nov 8.

  PMID: 27826777 RESULT

• Chevallay M, Jung M, Chon SH, Takeda FR, Akiyama J, Monig S. Esophageal cancer surgery: review of complications and their management. Ann N Y Acad Sci. 2020 Dec;1482(1):146-162. doi: 10.1111/nyas.14492. Epub 2020 Sep 15.

  PMID: 32935342 RESULT

MeSH Terms

Conditions

Esophageal Neoplasms

Interventions

Indocyanine Green

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Bin Zheng

CONTACT

15959002753; lacustrian@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: February 12, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): June 1, 2028
• Last Updated: February 12, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)