Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.
详细描述
This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age≥18 years;
- •Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
- •Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
- •Patients who have good compliance and sign informed consent.
排除标准
- •Diffuse GGO, suspected of benign or infectious lesions;
- •Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
- •Patients with contraindications of bronchoscopy;
- •Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
- •Pregnant or lactating women;
- •Patients with known allergy for fluorescein;
- •The investigators believe that patient has other conditions that are not suitable for the study.
研究组 & 干预措施
Patients with GGO-dominant peripheral pulmonary lesions
Approximately 119 patients with GGO-dominant PPLs who meet the inclusion and exclusion criteria will be prospectively enrolled. CLE and ssRAB-guided cryobiopsy will be performed to diagnose the lesion.
干预措施: CLE and ssRAB-guided cryobiopsy (Diagnostic Test)
结局指标
主要结局
Diagnostic yield
时间窗: 1 year
Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.
次要结局
- Diagnostic accuracy(1 year)
- Diagnostic sensitivity(1 year)
- Diagnostic specificity(1 year)
- Complication rate(1 month)
- CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.(1 year)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital