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Not yet recruiting NCT07745738

ICG Fluorescence Versus CO₂ Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy

No phase Interventional Pulmonary Nodule, Solitary

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Indocyanine Green Fluorescence Imaging, Carbon Dioxide Inflation-Deflation.
Who it may be relevant to
Registry conditions: Pulmonary Nodule, Solitary. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Comparison of Indocyanine Green Fluorescence and Carbon Dioxide Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy: A Prospective Paired Study

Overview

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

  • Procedure Indocyanine Green Fluorescence Imaging
    Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.
  • Procedure Carbon Dioxide Inflation-Deflation
    Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • 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]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07745738 · TJ-IRB202606104

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗