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Esophageal CancerPhase 3NCT07406815

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

A Phase 3 study testing ICG (Indocyanine Green) in people with Esophageal Cancer and Recurrent Laryngeal Nerve, run by Fujian Medical University Union Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
ICG (Indocyanine Green)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
144 participants
Where
1 siteChina
Study dates
1 Jun 2026to 1 Jun 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bin Zheng contact

15959002753

lacustrian@163.com

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

    Bin Zheng, 15959002753, lacustrian@163.com

Other trials in China

About this study

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

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.
Read the 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.

Being tested
ICG (Indocyanine Green)
Medical subject headings
Esophageal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ICG (Indocyanine Green)Drug

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

Study groups in NCT07406815
Study groupRoleWhat they receive
(ICG group) receiving VATS with near-infrared-indocyanine green fluorescence for RLN visualizationExperimentalNot described
Receives: Drug: ICG (Indocyanine Green)
(Control group) receiving VATS without near-infrared-indocyanine green fluorescence for RLN visualizNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: From enrollment to the end of surgery at 1 weeks

Secondary outcomes (8)

  1. 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.

    Measured: Repeat fiberoptic laryngoscopy at 1, 3, 6, and 12 months postoperatively.

  2. 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).

    Measured: 1 month after surgery

  3. 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.

    Measured: 1 week after surgery.

  4. 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.

    Measured: 30 days after surgery.

  5. 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.

    Measured: 30 days after surgery

  6. 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.

    Measured: 30 days after surgery.

  7. 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).

    Measured: 1 week after surgery.

  8. 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.

    Measured: 30 days after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Feb 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
144 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07406815
Sponsor's protocol ID
NERV-ICG
Status last verified
Dec 2025
First submitted
26 Nov 2024
Last updated
12 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25312996

  • 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.

    PubMed 32064788

  • 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.

    PubMed 20563722

  • 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.

    PubMed 27826777

  • 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.

    PubMed 32935342

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ICG (Indocyanine Green) in people with Esophageal Cancer and Recurrent Laryngeal Nerve, run by Fujian Medical University Union Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Bin Zheng (15959002753, lacustrian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Postoperative Recurrent Laryngeal Nerve Injury (time frame: From enrollment to the end of surgery at 1 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07406815, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.

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