Esophageal CancerNCT04615806
The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Esophagectomy
A study testing Indocyanine green solution in people with Esophageal Cancer and Indocyanine Green, run by Fujian Medical University Union Hospital at 1 site in China.
Trial summary
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Esophageal Cancer, Indocyanine Green
- What is being tested?
- Indocyanine green solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 22 Sep 2020to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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.
China1 site, 1 recruiting
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001
Bin Zheng, MD, 13023806690, Dujt1220@qq.com
About this study
Official title: The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.
Read the detailed description
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We 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.
- Conditions
- Esophageal Cancer, Indocyanine Green
- Being tested
- Indocyanine green solution
- Keywords
- Esophageal Cancer, Indocyanine Green, the lymph node markers
- Medical subject headings
- Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine green solutionDrug
Also called Indocyanine Green for Injection
ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
| Study group | Role | What they receive |
|---|---|---|
| NIR-ICG | Experimental | After positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml. Receives: Drug: Indocyanine green solution |
| Control | No intervention | This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy rate of lymph node dissection
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
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
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
Secondary outcomes (1)
The mapping of sentinel lymph nodes in esophageal cancer
The mapping of sentinel lymph nodes in esophageal cancer
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 posted4 Nov 2020
- Study start22 Sep 2020
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Medical University Union Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chun Chen, MD, Study director, Fujian Medical University Union Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04615806
- Sponsor's protocol ID
- ICG-NIR UNION
- Status last verified
- Jan 2022
- First submitted
- 27 Oct 2020
- Last updated
- 25 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Du J, Zeng T, Zhang S, Chen M, Huang G, Xu C, Xu G, Ni C, Hong R, Zheng W, Chen C, Zheng B. Comparison of indocyanine green-near-infrared fluorescence guided and traditional mediastinal lymphadenectomy during radical esophagectomy: A randomized controlled trial. Surgery. 2024 Feb;175(2):347-352. doi: 10.1016/j.surg.2023.10.007. Epub 2023 Nov 26.
PubMed 38012899Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29.
PubMed 35770339
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of Lymph Node Dissection of Indocyanine Green-guided Near-infrared Fluorescent Imaging in Video-assisted Thoracoscope Radical Esophagectomy
- ClinicalTrials.gov ID
- NCT04615806
- Acronym / sponsor ID
- ICG-NIR UNION
- Conditions
- Esophageal Cancer, Indocyanine Green
- Keywords
- Esophageal Cancer, Indocyanine Green, the lymph node markers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Fujian Medical University Union HospitalUniversity, hospital or other
- Study start
- 22 Sep 2020 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 4 Nov 2020 (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.
Indocyanine green (ICG) has been recently introduced in clinical practice as a fuorescent tracer. Lymphadenectomy is particularly challenging in esophageal cancer surgery, owing to the complex anatomical drainage.Therefore, the purpose of this study was to explore whether the NIR-ICG imaging system could accurately assess the lymph node markers during radical resection of esophageal cancer.
Detailed description
This study will be accepted in esophageal cancer patients with Radical Esophag-ectomy as the research object.We will divide them into two groups: experimental group for injection of indocyanine green group and control group for injectable in-docyanine green group.We 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 |
|---|---|---|
| NIR-ICG | Experimental | Drug: Indocyanine green solutionAfter positioning,Indocyanine green（ICG） dye (Yichuang Pharmaceutical, Liaoning, China) stored at a dose of 25 mg in a small bottle was diluted with 5 ml sterile water. Then, 2 ml of this solution was added to 8 ml sterile water in a dis-posable dressing bowl, resulting in a final concentration of 1.25 mg/ml. |
| Control | No intervention | –This group of patients received only conventional radical resection of esophageal cancer without Indocyanine green injection. |
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 |
|---|---|---|
| Indocyanine green solutionAlso: Indocyanine Green for InjectionICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor. | Drug | NIR-ICG |
Primary outcome
Accuracy rate of lymph node dissection
Time frame: 1 week after operation
Accuracy rate of lymph node dissection of each arm（according to postoperative pathology）
False positive rate of lymph node dissection
Time frame: 1 week after operation
False positive rate of lymph node dissectionof each arm（according to postoperative pathology）
False negative rate of lymph node dissection
Time frame: 1 week after operation
False negative rate of lymph node dissection of each arm（according to postoperative pathology）
Sensitivity and specificity of lymph node dissection
Time frame: 1 week after operation
Sensitivity and specificity of lymph node dissection of each arm（according to postoperative pathology）
1 secondary outcome
The mapping of sentinel lymph nodes in esophageal cancer
Time frame: 1 week after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2022.
- Derived from this study: PubMed 38012899Du J, Zeng T, Zhang S, Chen M, Huang G, Xu C, Xu G, Ni C, Hong R, Zheng W, Chen C, Zheng B. Comparison of indocyanine green-near-infrared fluorescence guided and traditional mediastinal lymphadenectomy during radical esophagectomy: A randomized controlled trial. Surgery. 2024 Feb;175(2):347-352. doi: 10.1016/j.surg.2023.10.007. Epub 2023 Nov 26.
- Derived from this study: PubMed 35770339Du J, Xu G, Yang Z, Zheng B, Chen C. Pericancerous lymph node imaging with indocyanine green-guided near-infrared fluorescence in radical esophagectomy: Protocol for a single-center, prospective, randomized controlled clinical trial. Thorac Cancer. 2022 Aug;13(15):2283-2287. doi: 10.1111/1759-7714.14548. Epub 2022 Jun 29.
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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. This study is not recruiting at the moment.
Chun Chen, MD study director
Fujian Medical University Union Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine green solution in people with Esophageal Cancer and Indocyanine Green, 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: status not confirmed, as of the sponsor's last update on 25 Jan 2022. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bin Zheng, MD (13023806690, Dujt1220@qq.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). The study lists 4 primary outcomes in all. 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 NCT04615806, which also lists 2 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 25 Jan 2022.