About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Indocyanine Green Fluorescence Imaging
Procedure/SurgeryIntravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Carbon Dioxide Inflation-Deflation
Procedure/SurgeryCarbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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 to intersegmental plane visualization
Time from completion of the identification procedure to visualization of a clearly identifiable intersegmental plane for each technique.
Technical success rate
Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique.
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.
Locations
Sponsors and contacts
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