Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer

NCT ID NCT07788001

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 26, 2026 · Last updated Aug 27, 2026 · Updated 1 time

Summary

This trial tests whether using a dye to identify and remove only the sentinel lymph nodes (the first nodes cancer might spread to) during esophageal cancer surgery is as effective as removing all nearby lymph nodes. The study includes 200 adults with early-stage esophageal squamous cell carcinoma who have not had prior treatment. If the dye-guided approach works, it could mean fewer surgical complications and better preservation of the immune system.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Indocyanine green (ICG), a dye injected around the tumor to highlight sentinel lymph nodes during surgery
What this could lead to
If successful, this could allow surgeons to remove fewer lymph nodes during esophageal cancer surgery, reducing complications while preserving immune function and maintaining cancer control.
What could go wrong
This is a non-inferiority trial, so it may show that the less extensive surgery is not as effective at preventing cancer recurrence. There is also a risk that the dye-guided technique misses metastatic lymph nodes.

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 200 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2031

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 1. Aged 18 to 75 years, regardless of gender; 2. Histopathologically confirmed esophageal squamous cell carcinoma or adenocarcinoma by endoscopic biopsy (including esophagogastric junction carcinoma, Siewert type I/II); 3. Preoperative clinical stage cT1-3N0M0 (based on contrast-enhanced CT ± PET-CT ± endoscopic ultrasound evaluation); 4. No prior neoadjuvant therapy of any form (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, targeted therapy, etc.); 5. Scheduled for minimally invasive radical esophagectomy (combined thoracoscopic and laparoscopic McKeown or Ivor-Lewis procedure); 6. No surgical contraindications, with cardiac, pulmonary, hepatic, and renal functions sufficient to tolerate surgery; 7. ECOG performance status score of 0 to 1; 8. Written informed consent signed by the patient or legal representative. Exclusion Criteria 1. Preoperative imaging clearly indicating lymph node metastasis (cN+) or distant metastasis (cM1); 2. Prior systemic or local treatment for esophageal cancer of any kind (including chemotherapy, radiotherapy, chemoradiotherapy, immunotherapy, etc.); 3. Previous history of esophageal or gastric surgery (except endoscopic mucosal resection/submucosal dissection); 4. History of allergy to iodine contrast agents or indocyanine green; 5. Severe hepatic or renal insufficiency (Child-Pugh class B or C; serum creatinine ≥ 1.5 times the upper limit of normal); 6. Uncontrolled hyperthyroidism; 7. Concomitant other malignancies requiring simultaneous treatment; 8. Pregnant or lactating women; 9. Other conditions deemed unsuitable for enrollment by the investigator. Withdrawal Criteria 1. Intraoperative exploration revealing inability to achieve radical resection (R2 resection) or extensive thoracic and abdominal metastasis; 2. Intraoperative exploration revealing definite lymph node metastasis (cN+) inconsistent with preoperative staging; 3. Severe allergic reaction after ICG injection requiring discontinuation of the study; 4. Intraoperative change of surgical plan due to severe complications; 5. Withdrawal of informed consent by the patient.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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  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

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Contacts and locations

Locations

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000, China

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