Pulmonary Nodule, Solitary
Conditions
Brief summary
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.
Interventions
PROCEDUREIndocyanine Green Fluorescence Imaging
Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
PROCEDURECarbon Dioxide Inflation-Deflation
Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
Sponsors
Tongji Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged 18 to 80 years. 2. Scheduled to undergo elective thoracoscopic anatomical segmentectomy. 3. Preoperative thin-section chest CT with three-dimensional reconstruction available for surgical planning. 4. Lesion considered suitable for anatomical segmentectomy by the thoracic surgery team. 5. Able and willing to provide written informed consent.
Exclusion criteria
1. Known allergy or contraindication to indocyanine green (ICG). 2. Pregnant or breastfeeding women. 3. Severe hepatic dysfunction or other conditions contraindicating the use of ICG. 4. Severe emphysema, bullous lung disease, diffuse pulmonary fibrosis, or other severe pulmonary parenchymal disease expected to interfere with intersegmental plane identification. 5. Conversion to thoracotomy before completion of both intersegmental plane identification methods.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference in tumor-to-plane distance (Δ margin) | Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation | 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 | 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. | Time from completion of the identification procedure to visualization of a clearly identifiable intersegmental plane for each technique. |
| Technical success rate | Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy. | Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique. |
| Perioperative safety | From surgery until hospital discharge | Perioperative adverse events related to indocyanine green (ICG) fluorescence imaging or carbon dioxide (CO₂) inflation-deflation, including allergic reactions, physiological changes, and intraoperative complications. |
Contacts
CONTACTZhang Ni Zhang Ni
Outcome results
None listed