An interventional study of Indocyanine Green Fluorescence Imaging and Carbon Dioxide Inflation-Deflation in Pulmonary Nodule, Solitary, sponsored by Tongji Hospital. Not yet recruiting. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-04.
Sponsored by Tongji Hospital · Not applicable, Interventional, and Other
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.
93 studies on the registry are indexed under Solitary Pulmonary Nodule; 20 are open to participants now.
This study's planned enrollment of 50 is below the median of 81 across 44 interventional studies indexed under Solitary Pulmonary Nodule.
Browse Solitary Pulmonary Nodule studies →Tongji Hospital is the lead sponsor of 386 studies on the registry; 209 are open to participants now.
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Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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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.
Procedure: Indocyanine Green Fluorescence Imaging · Procedure: Carbon Dioxide Inflation-Deflation
Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
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.
Time frame: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.
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).
Time frame: 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.
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
Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique.
Time frame: 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.
Time frame: From surgery until hospital discharge
No study locations are listed for this record.
Plan to share: Yes
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This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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