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Glowing dye could save voices in esophageal cancer surgery

NCT ID NCT07406815

Disease control Sponsor: Fujian Medical University Union Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a dye called indocyanine green (ICG), given before surgery, can help surgeons see and protect the recurrent laryngeal nerve during esophageal cancer removal. About 144 adults with esophageal cancer will be randomly assigned to get the dye or standard surgery. The goal is to see if the dye lowers the chance of nerve injury, which can cause voice hoarseness and swallowing problems.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 144 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. * 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.

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Conditions

The condition(s) this trial relates to.

esophageal cancer Esophageal Neoplasms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Esophageal cancer Icg (indocyanine green) Lymph node dissection Recurrent laryngeal nerve

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.