Dye-Guided surgery may spare healthy lymph nodes in esophageal cancer
NCT ID NCT07788001
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000, China
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Other studies related to the condition(s) this trial covers.
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- Can repeated MRI scans reveal how tumors respond to radiation?