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

NCT07745738 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202606104
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Nodule, Solitary

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Difference in tumor-to-plane distance (Δ margin)

  Immediately after removal of the resected specimen during the surgical procedure and before formalin fixation

• 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.

• Technical success rate

  Intraoperative, at completion of each intersegmental plane identification technique and before pulmonary parenchymal division during thoracoscopic segmentectomy.

• Perioperative safety

  From surgery until hospital discharge

Study Arms (1)

Single Group

EXPERIMENTAL

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; Procedure: Carbon Dioxide Inflation-Deflation

Interventions

Indocyanine Green Fluorescence Imaging PROCEDURE

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

Single Group

Carbon Dioxide Inflation-Deflation PROCEDURE

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

Single Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Solitary Pulmonary Nodule

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Zhang Ni Zhang Ni

CONTACT

+8613006315393; zhangnidoc@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: August 4, 2026
• Study Start: July 15, 2026
• Primary Completion (Estimated): September 15, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 4, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share