A Randomized Trial of Cryoprobe Versus Forceps for Transbronchial Biopsy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 13
- 主要终点
- Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
研究概览
简要总结
The purpose of this study is to compare the effectiveness of transbronchial biopsy done by a 1.1mm cryoprobe versus the standard 2.0mm forceps.
详细描述
A smaller (1.1mm), flexible, single-use cryoprobe with an oversheath has been developed that can be used for transbronchial biopsies. This device has the potential to gather larger and higher quality tissue samples than the standard method using forceps, and with potentially fewer complications than older, larger versions of the cryoprobe.
For this study, patients will be randomized in a 1:1 fashion to transbronchial biopsy using a 1.1 mm cryoprobe versus 2.0 mm forceps, stratified by indication (evaluation of lung transplant allograft, diffuse parenchymal lung disease or pulmonary parenchymal lesion). Blinding of the proceduralist is not possible due to the nature of the procedure. Pathologists interpreting the biopsy samples will be blinded to the biopsy device used.
Patients enrolled in this study will have data collected by research staff for up to 30 days after the bronchoscopic biopsy procedure is performed. This 30-day follow-up period is the standard of care following bronchoscopic biopsy procedures.
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
- Double (Participant, Outcomes Assessor)
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
- •Male or Female, ≥ 18-years-old
- •Scheduled to undergo bronchoscopy with transbronchial biopsy per standard of care
排除标准
- •Pregnant or nursing woman or woman of child-bearing potential who refuse to take a pregnancy test prior to enrollment
- •Severe pulmonary hypertension (RVSP > 60 mmHg)
- •Stroke within the last 6 months or myocardial infarction within the last 3 months
- •Presence of bleeding disorder
- •Platelet count < 50,000 per mL at time of enrollment
- •Use of systemic anticoagulation or antiplatelet therapy without the ability to hold therapy for the recommended time prior to invasive procedure (aspirin monotherapy is acceptable)
- •Do Not Resuscitate (DNR) status
- •Do Not Intubate (DNI) status
研究组 & 干预措施
Forceps
Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using forceps
干预措施: Radial Jaw 4 Pulmonary Biopsy Forceps (Device)
Cryoprobe
Participants in this arm will undergo a standard of care bronchoscopy with a transbronchial biopsy using the 1.1mm sheath cryoprobe
干预措施: ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651 (Device)
结局指标
主要结局
Diagnostic yield as assessed by number of patients for which the procedure led to a diagnosis
时间窗: During procedure, up to 1 hour
Diagnostic Yield as Assessed by Number of Patients for Which the Procedure \[Cryobiopsy or Forceps\] Led to a Diagnosis.
次要结局
- Number of deaths(Within 30 days of procedure)
- Diagnostic yield for pulmonary parenchymal lesions(During procedure, up to 1 hour)
- Diagnostic yield for diffuse parenchymal lung disease(During procedure, up to 1 hour)
- Diagnostic yield for Lung Transplant(During procedure, up to 1 hour)
- Histological Accessibility grade of the biopsy specimen(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Pneumothorax Complication Rate(Within 30 days of procedure)
- Alveolated Area(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Procedure Time(At the time of procedure, up to 1 hour)
- Bleeding Complication Rate(Within 30 days of procedure)
- Adequacy for Molecular Testing(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Total Histologic Area(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Artifact-free lung parenchyma(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Post-Procedure Respiratory Failure Rate(Within 30 days of procedure)
- Percent Crush Artifact(Participants assessed for the outcome measure at the time of biopsy procedure (up to 1 hour))
- Activation Time(At the time of procedure, up to 1 hour)