A Comparative Study on the Diagnostic Efficacy of Confocal Laser Endomicroscopy Versus Rapid On-Site Evaluation (ROSE) for Ex Vivo Lung Biopsy Specimens Obtained Via Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions
研究概览
简要总结
The goal of this observational study is to evaluate the diagnostic efficacy of Confocal Laser Endomicroscopy (CLE) compared to Rapid On-Site Evaluation (ROSE) for ex vivo lung biopsy specimens obtained via bronchoscopy. The main questions it aims to answer are:
- Does CLE provide diagnostic accuracy comparable to ROSE for the real-time assessment of peripheral pulmonary lesions?
- What is the level of consistency between CLE-detected malignant architectural patterns and ROSE-identified atypical cells? Participants with peripheral pulmonary lesions (5-50 mm) undergoing navigational bronchoscopy will have their first retrieved biopsy specimen sequentially analyzed. The specimen will undergo CLE scanning first, followed immediately by ROSE cytology, before being fixed for final histopathological examination (the gold standard). CLE and ROSE interpreters will be blinded to the final pathological results and to each other's findings. Diagnostic performance, inter-modality agreement (using Kappa statistics), and procedure times will be analyzed to determine if CLE can serve as a non-consumptive alternative to ROSE.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •（1）Imaging Findings: Presence of a peripheral pulmonary lesion (PPL) measuring 5 to 50 mm in maximum diameter on chest CT scan.
- •（2）Clinical Indication: Patients with a clinical indication for diagnostic flexible bronchoscopy and transbronchial biopsy.
- •（3）Consent: Provision of signed and dated written informed consent prior to any study-specific procedures.
排除标准
- •（1）Contraindications to Bronchoscopy: Patients with severe cardiopulmonary insufficiency or any absolute contraindication to flexible bronchoscopy (e.g., severe hypoxemia, unstable angina, or uncontrolled asthma).
- •（2）Coagulopathy: Patients with severe coagulation disorders (e.g., platelets <50,000/μL, INR >1.5) not corrected prior to the procedure.
- •（3）Pregnancy/Lactation: Pregnant or lactating women.
结局指标
主要结局
Diagnostic accuracy of ex vivo CLE versus ROSE for malignancy detection in peripheral pulmonary lesions
时间窗: Intraoperative - within 30 minutes of each biopsy specimen retrieval
Using final histopathology as the gold standard, diagnostic accuracy (proportion of correct benign/malignant classifications) will be calculated for both ex vivo confocal laser endomicroscopy (CLE) and rapid on-site evaluation (ROSE). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy with 95% confidence intervals will be derived from 2×2 contingency tables for each modality.
次要结局
- Cohen's kappa (κ) for agreement between CLE diagnosis and final histopathology(After final pathology available (within 7-10 working days))
- Diagnostic performance of ex vivo CLE(Intraoperative)
- Diagnostic performance of ROSE(Intraoperative)
- Cohen's kappa (κ) for agreement between CLE structural findings and ROSE cytological findings on the same specimen(Intraoperative interpretations, validated post-pathology)
- Procedure time: CLE imaging and interpretation time per specimen(Intraoperative)
- Procedure time: ROSE preparation and interpretation time per specimen(Intraoperative)
研究者
Li Shiyue
professor
The First Affiliated Hospital of Guangzhou Medical University