Comparison of Indocyanine Green Fluorescence and Carbon Dioxide Inflation-Deflation for Intersegmental Plane Identification During Thoracoscopic Segmentectomy: A Prospective Paired Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 主要终点
- Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical concordance of the intersegmental planes identified by indocyanine green fluorescence imaging and carbon dioxide inflation-deflation
时间窗: 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.
次要结局
- 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)