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NCT Number: NCT07745738

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

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.

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Key information

Conditions

Pulmonary Nodule, Solitary Lung Diseases Respiratory Tract Diseases Solitary Pulmonary Nodule

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Indocyanine Green Fluorescence Imaging

Procedure

Intravenous indocyanine green (ICG) fluorescence imaging is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.

Carbon Dioxide Inflation-Deflation

Procedure

Carbon dioxide (CO₂) inflation-deflation is used intraoperatively to identify the intersegmental plane during thoracoscopic anatomical segmentectomy.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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).

  2. 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.

    Time from completion of the identification procedure to visualization of a clearly identifiable intersegmental plane for each technique.

  3. Technical success rate

    Time frame: 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.

  4. Perioperative safety

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhang Ni Zhang Ni

CONTACT

[email protected]

+8613006315393

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 4, 2026
Registry last updated
Aug 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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