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

N/ANot Yet RecruitingNCT07745738

Tongji Hospital50 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Pulmonary Nodule, Solitary

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: Intraoperative, after both intersegmental boundaries have been identified and marked and immediately before pulmonary parenchymal division during thoracoscopic segmentectomy.

Secondary Outcomes

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).

Time frame: 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.

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

Proportion of procedures in which a clearly identifiable intersegmental plane is successfully visualized using each technique.

Time frame: 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.

Time frame: From surgery until hospital discharge