Prospective Controlled Study of Transbronchial Cryoprobe Versus Forceps Biopsy for Acute Rejection in Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)
研究概览
简要总结
Lung transplant recipients undergo bronchoscopy with biopsies for clinical indications and for surveillance in the diagnosis of acute rejection using standard transbronchial forceps. It is recognized that standard forceps biopsies underestimate the presence or degree of airway rejection due to crush artifact and sample size. Transbronchial cryobiopsies have been shown in the literature to provide larger samples without crush artifact in a safe fashion in lung cancer patients. The aim of this study is to determine if transbronchial cryobiopsy is superior to standard transbronchial forceps biopsies in regards to sample size, architecture and the diagnosis of early rejection in lung transplant recipients which if discovered earlier may improve survival.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals referred for either clinically indicated or surveillance flexible bronchoscopy will be included in the study population
- •Age greater than 18 years and having undergone bilateral orthotopic lung transplantation
排除标准
- •Coagulopathy: plts < 50,000 international normalized ratio (INR) > 1.5
- •Forced expiratory volume at one second (FEV1) < 0.8
- •Diffuse bullous disease
- •Hemodynamic instability
- •Severe hypoxemia
研究组 & 干预措施
Cryoprobe biopsy
All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
干预措施: Cryoprobe biopsy (Procedure)
Forceps Biopsy
All patients enrolled will undergo standard forceps biopsies followed by cryoprobe biopsies and results will be compared
干预措施: Forceps Biopsy (Procedure)
结局指标
主要结局
Differences in size of biopsy specimen and architectural preservation of the airways/alveoli (ie degree of crush artifact)
时间窗: From date of study enrollment until the patient is 2 years post lung transplant
Direct measurements of pathologic specimens from the forceps and cryoprobe will be compared. In addition, amount of crush artifact will alse be directly measured and compared utilizing pathology software which measures area of viable tissue.
次要结局
- Diagnostic yield (ie presence of acute cellular rejections (ACR), chronic rejection, lymphocytic bronchiolitis and infection)(From date of study enrollment until the patient is 2 years post lung transplant)