Esophageal CancerPhase 3NCT07303231
The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy
A Phase 3 study testing Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node in people with Esophageal Cancer and Sentinel Lymph Node, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Sentinel Lymph Node, Lymphadenectomy
- What is being tested?
- Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2026to 1 Feb 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 and gender: 18-75 years old, male and female unlimited;
- Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
- Preoperative combination with neoadjuvant chemoradiotherapy;
- Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
- Heart, lung, liver and kidney functions can tolerate operation;
- Patients and their family members can understand and are willing to participate in this clinical study and sign the informed consent.
Who cannot join
- Allergic to ICG or iodine;
- Patients with a history of chest surgery or thoracic lymph node dissection;
- Patients needing emergency surgery;
- Patients whose tumors involve neighboring organs and need to be removed by combining organs;
- Patients with tumor recurrence or distant metastasis;
- Patients who had participated in or were participating in other clinical trials within the previous 4 weeks were included;
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- A history of serious mental illness;
- Pregnant or lactating women;
- Patients with other conditions considered by the researcher should not participate in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350000
Bin Zheng, 15959002753, lacustrian@163.com
About this study
Official title: The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy: A Multicenter Prospective Cohort Study
Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:
- In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection?
- In ESCC patients undergoing surgery, can reducing lymph node dissection decrease postoperative complications such as chylothorax and weakened immunity? During the study, ICG will be injected around the tumor under intraoperative gastroscopy guidance, followed by tracking of fluorescent lymph nodes using a thoracoscopic near-infrared camera. Professional thoracic surgeons will group and mark these lymph nodes for intraoperative frozen pathology. Subsequent CLND and routine postoperative pathology will be performed. This study will collect patients' clinical information, ICG imaging results, pathological examination results, and other data for statistical analysis to assess the sensitivity and negative predictive value (NPV) of the ICG imaging system. If the study results support the effectiveness of the ICG imaging system, it has the potential to become an important tool for sentinel lymph node localization and biopsy in future ESCC surgeries, helping to reduce unnecessary lymph node resection and improve surgical efficiency and safety.
Read more
Participants will:
- Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day.
- Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery.
- Have perioperative, postoperative pathology, and complication information recorded.
- Undergo standardized follow-up after surgery.
Read the detailed description
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object. The investigators will divide participants into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.The investigators will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.
- Being tested
- Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph nodeDrug
A multicenter, prospective cohort study will be conducted. Enrolled patients with esophageal squamous cell carcinoma will undergo minimally invasive radical esophagectomy. During surgery, ICG will be injected around the tumor under gastroscopy guidance, and fluorescent lymph nodes will be tracked using a thoracoscopic near-infrared camera. These lymph nodes will be grouped and marked by professional thoracic surgeons, and intraoperative frozen pathology results will be recorded. Subsequent CLND will be performed. The study will collect and analyze patients' clinical information, ICG imaging results, and pathological examination results to explore the effectiveness of the ICG imaging system.
| Study group | Role | What they receive |
|---|---|---|
| (ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize | Experimental | Not described Receives: Drug: Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node |
| (Control group) receiving VATS without near-infrared imaging with indocyanine g | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy rate of lymph node dissection
According to postoperative pathological results, investigate the detection rate of metastatic lymph nodes using the near-infrared indocyanine green fluorescence imaging system in lymph node dissection for esophageal squamous cell carcinoma
Measured: 1 week after operation
Secondary outcomes (4)
Sensitivity and specificity of lymph node dissection
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
Measured: 1 week after operation
The number of lymph nodes
The number of lymph nodes between the both groups
Measured: 1 week after operation
False positive rate of lymph node dissection
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
Measured: 1 week after operation
False negative rate of lymph node dissection
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Measured: 1 week after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal CancerStudies of the same condition, open and under way.
- More trials run by Fujian Medical University Union HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Cancer Hospital, The First Affiliated Hospital of Xiamen University, The University of Hong Kong
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07303231
- Sponsor's protocol ID
- LYNX-ICG
- Status last verified
- May 2025
- First submitted
- 19 Jan 2025
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Indocyanine Green-guided Near-infrared Fluorescence Technology in Tracing Sentinel Lymph Nodes During Esophagectomy: A Multicenter Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07303231
- Acronym / sponsor ID
- LYNX-ICG
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Collaborators
- Henan Cancer Hospital, The First Affiliated Hospital of Xiamen University, The University of Hong Kong
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sentinel lymph nodes, as the primary site of tumor metastasis, play a pivotal role in assessing patient prognosis and planning subsequent treatment strategies. The investigators plan to conduct a multicenter, prospective cohort study to evaluate the effectiveness of indocyanine green (ICG)-guided near-infrared imaging in tracing sentinel lymph node during esophageal squamous cell carcinoma (ESCC) surgery, compared with the gold standard of complete lymph node dissection (CLND), in detecting metastatic disease. This study aims to address the following core questions:
- In ESCC patients undergoing surgery, can sentinel lymph node biopsy reduce unnecessary lymph node dissection?
- In ESCC patients undergoing surgery, can reducing lymph node dissection decrease postoperative complications such as chylothorax and weakened immunity? During the study, ICG will be injected around the tumor under intraoperative gastroscopy guidance, followed by tracking of fluorescent lymph nodes using a thoracoscopic near-infrared camera. Professional thoracic surgeons will group and mark these lymph nodes for intraoperative frozen pathology. Subsequent CLND and routine postoperative pathology will be performed. This study will collect patients' clinical information, ICG imaging results, pathological examination results, and other data for statistical analysis to assess the sensitivity and negative predictive value (NPV) of the ICG imaging system. If the study results support the effectiveness of the ICG imaging system, it has the potential to become an important tool for sentinel lymph node localization and biopsy in future ESCC surgeries, helping to reduce unnecessary lymph node resection and improve surgical efficiency and safety.
Participants will:
- Undergo minimally invasive ESCC surgery within 2 weeks of enrollment, including the 14th day.
- Receive ICG injection around the tumor under intraoperative gastroscopy guidance during surgery.
- Have perioperative, postoperative pathology, and complication information recorded.
- Undergo standardized follow-up after surgery.
Detailed description
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object. The investigators will divide participants into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.The investigators will compare with the accuracy,false positive rate and false negative rate,sensitivity, specificity and related indicators of intraoperative lymph node cleaning,in order to explore the common position of esophageal cancer sentinel lymph node,guidance of esophageal cancer lymph node cleaning thoroughly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize | Experimental | Drug: Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node |
| (Control group) receiving VATS without near-infrared imaging with indocyanine g | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age and gender: 18-75 years old, male and female unlimited;
- Preoperative biopsy was pathologically diagnosed as esophageal squamous cell carcinoma;
- Preoperative combination with neoadjuvant chemoradiotherapy;
- Surgical resection of esophageal carcinoma under endoscopic selection and intraoperative anastomosis;
- Heart, lung, liver and kidney functions can tolerate operation;
Key exclusion criteria (9 listed)
- Allergic to ICG or iodine;
- Patients with a history of chest surgery or thoracic lymph node dissection;
- Patients needing emergency surgery;
- Patients whose tumors involve neighboring organs and need to be removed by combining organs;
- Patients with tumor recurrence or distant metastasis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph nodeA multicenter, prospective cohort study will be conducted. Enrolled patients with esophageal squamous cell carcinoma will undergo minimally invasive radical esophagectomy. During surgery, ICG will be injected around the tumor under gastroscopy guidance, and fluorescent lymph nodes will be tracked using a thoracoscopic near-infrared camera. These lymph nodes will be grouped and marked by professional thoracic surgeons, and intraoperative frozen pathology results will be recorded. Subsequent CLND will be performed. The study will collect and analyze patients' clinical information, ICG imaging results, and pathological examination results to explore the effectiveness of the ICG imaging system. | Drug | (ICG group) receiving VATS with near-infrared imaging with indocyanine green to visualize |
Primary outcome
Accuracy rate of lymph node dissection
Time frame: 1 week after operation
According to postoperative pathological results, investigate the detection rate of metastatic lymph nodes using the near-infrared indocyanine green fluorescence imaging system in lymph node dissection for esophageal squamous cell carcinoma
4 secondary outcomes
Sensitivity and specificity of lymph node dissection
Time frame: 1 week after operation
The number of lymph nodes
Time frame: 1 week after operation
False positive rate of lymph node dissection
Time frame: 1 week after operation
False negative rate of lymph node dissection
Time frame: 1 week after operation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Minimally invasive surgery for esophageal cancer using near-infrared indocyanine green fluorescence to visualize the sentinel lymph node in people with Esophageal Cancer and Sentinel Lymph Node, 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 6 inclusion and 9 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 24 Dec 2025. 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, M.D. (15959002753, lacustrian@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy rate of lymph node dissection (time frame: 1 week after operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Dec 2025.