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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pulmonary Nodule, Solitary
• Intervention / Treatment: Procedure: Indocyanine Green Fluorescence Imaging; Procedure: Carbon Dioxide Inflation-Deflation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zhang Ni Zhang Ni; Phone Number: +8613006315393; Email: zhangnidoc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Single Group; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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.	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.	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.	From surgery until hospital discharge

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): July 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: August 2, 2026
• First Posted (Actual): August 4, 2026

Study Record Updates

• Last Update Posted (Actual): August 4, 2026
• Last Update Submitted That Met QC Criteria: August 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Solitary Pulmonary Nodule
• Other Study ID Numbers: TJ-IRB202606104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No