Pulmonary Nodule, SolitaryNCT07745738
ICG Fluorescence Versus CO₂ Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy
A study testing Indocyanine Green Fluorescence Imaging and Carbon Dioxide Inflation-Deflation in people with Pulmonary Nodule, Solitary, run by Tongji Hospital.
Trial summary
Intersegmental plane identification is a critical step in thoracoscopic anatomical segmentectomy because it helps ensure adequate surgical margins while preserving healthy lung tissue. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Pulmonary Nodule, Solitary
- What is being tested?
- Indocyanine Green Fluorescence Imaging and Carbon Dioxide Inflation-Deflation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2026to 30 Sep 2026
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 to 80 years.
- Scheduled to undergo elective thoracoscopic anatomical segmentectomy.
- Preoperative thin-section chest CT with three-dimensional reconstruction available for surgical planning.
- Lesion considered suitable for anatomical segmentectomy by the thoracic surgery team.
- Able and willing to provide written informed consent.
Who cannot join
- Known allergy or contraindication to indocyanine green (ICG).
- Pregnant or breastfeeding women.
- Severe hepatic dysfunction or other conditions contraindicating the use of ICG.
- Severe emphysema, bullous lung disease, diffuse pulmonary fibrosis, or other severe pulmonary parenchymal disease expected to interfere with intersegmental plane identification.
- Conversion to thoracotomy before completion of both intersegmental plane identification methods.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Indocyanine Green Fluorescence and Carbon Dioxide Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy: A Prospective Paired Study
Intersegmental plane identification is a critical step in thoracoscopic anatomical segmentectomy because it helps ensure adequate surgical margins while preserving healthy lung tissue. Indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation are two techniques used to identify the intersegmental plane, but their agreement and clinical applicability have not been adequately evaluated.
This prospective paired study aims to compare the intersegmental planes identified by ICG fluorescence imaging and the CO₂ inflation-deflation method during thoracoscopic anatomical segmentectomy. In each participant, both techniques will be performed during the same operation, and the identified intersegmental planes will be compared. The findings of this study may provide evidence regarding the agreement and clinical applicability of the two methods for intersegmental plane identification.
- Conditions
- Pulmonary Nodule, Solitary
- Being tested
- Indocyanine Green Fluorescence Imaging, Carbon Dioxide Inflation-Deflation
- Medical subject headings
- Solitary Pulmonary Nodule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indocyanine Green Fluorescence ImagingProcedure or surgery
Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Carbon Dioxide Inflation-DeflationProcedure or surgery
Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
| Study group | Role | What they receive |
|---|---|---|
| Single Group | Experimental | Participants undergoing thoracoscopic anatomical segmentectomy will undergo intersegmental plane identification using indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation during the same surgical procedure. The intersegmental planes identified by the two techniques will be compared to evaluate their clinical concordance and intraoperative performance. The final parenchymal transection line will be determined by the operating surgeon according to intraoperative clinical judgment. Receives: Procedure: Indocyanine Green Fluorescence Imaging; Procedure: Carbon Dioxide Inflation-Deflation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation
Clinical concordance between the intersegmental planes identified by the two techniques, determined by blinded assessment of de-identified intraoperative videos. Concordance is defined as Grade A or Grade B agreement; discordance is defined as Grade C.
Measured: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.
Secondary outcomes (4)
Difference in tumor-to-plane distance (Δ margin)
Difference in the shortest distance from the tumor to the intersegmental plane identified by carbon dioxide (CO₂) inflation-deflation and indocyanine green (ICG) fluorescence imaging, measured on the resected specimen (Δ margin = CO₂ - ICG).
Measured: Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation
Time to intersegmental plane visualization
Time from completion of the identification procedure to visualization of a clearly identifiable intersegmental plane for each technique.
Measured: Intraoperative, from completion of ICG injection or complete CO₂ reinflation to first visualization of the respective intersegmental boundary, before pulmonary parenchymal division during thoracoscopic segmentectomy.
Technical success rate
Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique.
Measured: Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy.
Perioperative safety
Perioperative adverse events related to indocyanine green (ICG) fluorescence imaging or carbon dioxide (CO₂) inflation-deflation, including allergic reactions, physiological changes, and intraoperative complications.
Measured: From surgery until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start15 Jul 2026 (estimated)
- Primary completion15 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhang Ni, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745738
- Sponsor's protocol ID
- TJ-IRB202606104
- Status last verified
- Jul 2026
- First submitted
- 11 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Indocyanine Green Fluorescence and Carbon Dioxide Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy: A Prospective Paired Study
- ClinicalTrials.gov ID
- NCT07745738
- Acronym / sponsor ID
- TJ-IRB202606104
- Conditions
- Pulmonary Nodule, Solitary
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 15 Jul 2026 (estimated)
- Primary completion
- 15 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 4 Aug 2026 (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.
Intersegmental plane identification is a critical step in thoracoscopic anatomical segmentectomy because it helps ensure adequate surgical margins while preserving healthy lung tissue. Indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation are two techniques used to identify the intersegmental plane, but their agreement and clinical applicability have not been adequately evaluated.
This prospective paired study aims to compare the intersegmental planes identified by ICG fluorescence imaging and the CO₂ inflation-deflation method during thoracoscopic anatomical segmentectomy. In each participant, both techniques will be performed during the same operation, and the identified intersegmental planes will be compared. The findings of this study may provide evidence regarding the agreement and clinical applicability of the two methods for intersegmental plane identification.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Group | Experimental | Procedure: Indocyanine Green Fluorescence Imaging, Procedure: Carbon Dioxide Inflation-DeflationParticipants undergoing thoracoscopic anatomical segmentectomy will undergo intersegmental plane identification using indocyanine green (ICG) fluorescence imaging and carbon dioxide (CO₂) inflation-deflation during the same surgical procedure. The intersegmental planes identified by the two techniques will be compared to evaluate their clinical concordance and intraoperative performance. The final parenchymal transection line will be determined by the operating surgeon according to intraoperative clinical judgment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 to 80 years.
- Scheduled to undergo elective thoracoscopic anatomical segmentectomy.
- Preoperative thin-section chest CT with three-dimensional reconstruction available for surgical planning.
- Lesion considered suitable for anatomical segmentectomy by the thoracic surgery team.
- Able and willing to provide written informed consent.
Key exclusion criteria (5 listed)
- Known allergy or contraindication to indocyanine green (ICG).
- Pregnant or breastfeeding women.
- Severe hepatic dysfunction or other conditions contraindicating the use of ICG.
- Severe emphysema, bullous lung disease, diffuse pulmonary fibrosis, or other severe pulmonary parenchymal disease expected to interfere with intersegmental plane identification.
- Conversion to thoracotomy before completion of both intersegmental plane identification methods.
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 Fluorescence ImagingIntravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy. | Procedure or surgery | Single Group |
| Carbon Dioxide Inflation-DeflationCarbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy. | Procedure or surgery | Single Group |
Primary outcome
Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation
Time frame: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.
Clinical concordance between the intersegmental planes identified by the two techniques, determined by blinded assessment of de-identified intraoperative videos. Concordance is defined as Grade A or Grade B agreement; discordance is defined as Grade C.
4 secondary outcomes
Difference in tumor-to-plane distance (Δ margin)
Time frame: Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation
Time to intersegmental plane visualization
Time frame: Intraoperative, from completion of ICG injection or complete CO₂ reinflation to first visualization of the respective intersegmental boundary, before pulmonary parenchymal division during thoracoscopic segmentectomy.
Technical success rate
Time frame: Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy.
Perioperative safety
Time frame: From surgery until hospital discharge
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 4 Aug 2026.
- Individual participant dataSharing planned: Yes
Related trials for Pulmonary Nodule, Solitary
RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
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.
Questions about this trial
What is this clinical trial studying?
A study testing Indocyanine Green Fluorescence Imaging and Carbon Dioxide Inflation-Deflation in people with Pulmonary Nodule, Solitary, run by Tongji Hospital.
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 5 inclusion and 5 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Zhang Ni Zhang Ni (+8613006315393, zhangnidoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation (time frame: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.). 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 4 Aug 2026.