The Efficacy and Safety of Transbronchial Cryobiopsy vs Forceps Biopsy in the Diagnosis of Lung Ground-glass Opacity: A Prospective, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Diagnostic yield
研究概览
简要总结
The aim of this study is to investigate the difference of efficacy and safety between transbronchial cryobiopsy (TBCB) and transbronchial forceps biopsy (TBFB) in the diagnosis of lung ground-glass opacity.
详细描述
The conventional biopsy method for lung ground-glass opacity (GGO) diagnosis is to use disposable guided sheath (including biopsy forceps and cell brushes) which have some limitations, such as big physical damage, small biopsy tissue, etc. Cryobiospy is a new technique for biopsy developed in recent years which has many advantages over conventional biopsy, such as larger tissue, higher diagnosis yield, less complication, etc. The investigators will explore the efficacy and safety of cryobiospy vs. biopsy forceps in GGO diagnosis. The study is designed as a prospective, randomized controlled trial, 184 patients will be expected to enroll in the study and receive EBUS examination before biopsy to check whether the GGO lesions exist or not. This is a parallel-control study that patients with GGO lesions will be randomized to either TBCB group or TBFB group for biopsy. The primary aim is to compare the diagnostic yields of the two biopsy techniques. The secondary endpoint is to assess the tissue size, sampling time, number of sampling and the quality of specimen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- •Male or female aged between 18 and
- •CT or other imaging examination suggest a tendency towards malignant GGO (size ≥ 8 mm). The ground glass composition is more than 50%.
- •Thin-slice CT scan with bronchial access or adjacent lesions.
- •Multidisciplinary assessment suggest that bronchopulmonary biopsy is needed to identify the pathological features of GGO.
- •It is suitable for pathological biopsy by transbronchial cryobiopsy or forceps biopsy.
- •Ability to read, understand and sign ICF.
排除标准
- •Disseminated GGO, suspected of benign or infectious lesions.
- •Preoperative imaging examination showed that the biopsy lesion was adjacent to the middle or large vessels.
- •There are contraindications for bronchoscopy, such as irreparable coagulation dysfunction, severe cardiopulmonary insufficiency.
- •Intolerance or difficulty in cooperating with bronchoscopy, etc.
- •Routine bronchoscopic abnormalities, such as endoscopic lesions, external pressure, mucosal lesions, stenosis, hemorrhage, etc.
- •Vulnerable groups, such as pregnant women, etc.
- •Some other special situations investigator consider subjects are not suitable to participant in this study.
结局指标
主要结局
Diagnostic yield
时间窗: Up to 6 Months
Diagnostic yield of transbronchial cryobiopsy (TBCB) or transbronchial forceps biopsy (TBFB) for lung ground-glass opacity.
次要结局
- Tissue size(Up to 1 months)
研究者
Jiayuan Sun
Director, Department of Respiratory Endoscopy
Shanghai Chest Hospital