NCT04548830已完成2 期
Safety of Transbronchial Cryobiopsy in a Cancer Population
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Post Cryobiopsy complications
研究概览
简要总结
The purpose of this study is to find out whether a biopsy technique called transbronchial cryobiopsy (TBCB) is a safe alternative to the standard biopsy procedure (transbronchial forceps biopsy; TBFB). The study researchers think that TBCB may provide better biopsy samples to help diagnose lung disease.
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
- •18 years of age or greater
- •Patients with known or suspected diagnosis of cancer and indeterminant pulmonary nodules or diffuse parenchymal lung disease with non-diagnostic clinical profiles for whom a lung biopsy is deemed useful for diagnosis.
排除标准
- •Patients with pulse oximetry less than 92% on oxygen delivery up to 2 L nasal cannula.
- •Uncorrectable coagulopathy defined as:
- •Platelet count <50,000 x 10^9/L or
- •prothrombin time international normalized ratio >1.5
- •Known pulmonary hypertension or echocardiographic pulmonary artery systolic pressure >50mmHg
- •A secure diagnosis based on clinical and high-resolution CT scan data.
- •Antiplatelet therapy that cannot be held for more than 5 days.
- •Any patient deemed unfit to undergo bronchoscopy by the proceduralist
- •Female patients with a positive pregnancy test within 30 days of the planned study procedure
研究组 & 干预措施
Transbronchial cryobiopsy
Experimental
All study participants will undergo transbronchial biopsies via our proposed standardized cryo-biopsy protocol in place of the traditional forceps transbronchial biopsy that is typically used at MSK.
干预措施: Transbronchial cryobiopsy (Procedure)
结局指标
主要结局
Post Cryobiopsy complications
时间窗: 2 years
will be graded according to Common Terminology Criteria for Adverse Events version 5 (CTCAE v5)
次要结局
未报告次要终点
研究者
研究点 (1)
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