Comparison of Transbronchial Cryobiopsy and Forceps Biopsy in Lung Transplant Recipients: A Prospective Analysis for Acute Cellular Rejection
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- diagnostic yield
研究概览
简要总结
CLAD is defined as loss of lung function after other factors, particularly infections have been excluded. Readily accessible diagnostic procedures to detect acute cellular rejection at the earliest possible occasion is crucial for posttransplant survival. Serial lung function tests, laboratory testing and pulmonary imaging are only clinical indicators of chronic allograft dysfunction in lung transplant recipients. Since forceps biopsy to detect acute cellular rejection in lung transplant recipients has several shortcomings, the purpose of this study is to investigate a new biopsy technique using the transbronchial cryoprobe.
详细描述
Eventually, histopathological confirmation is indispensable to establish the diagnosis of acute cellular rejection. The current gold standard for diagnosis and grading of acute cellular rejection in order to initialize the optimal treatment, with particular regard to adjusting immunosuppression, is forceps biopsy to obtain ≥ five samples. Forceps biopsy has a reasonable risk profile in experienced centers and is performed 2, 4, 6 and 12 months posttransplant and when indicated. Given these concerns about diagnostic yield in forceps biopsy and unjustifiable risks after surgical lung biopsy, cryobiopsy has arisen as promising alternative diagnostic procedure. The value of cryobiopsy to obtain a conclusive diagnosis of ACR is discussed controversially due the lack of safety and efficacy data in lung transplant recipients
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
- 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
- •routinely performed surveillance bronchoscopy and when indicated including serial FB and CB in the same session in patients wo had undergone lung transplant
- •male or female subject of at least 18 years of age
- •written informed consent after participant's information signed by patient
排除标准
- •age < 18 years
- •Lacking ability to form an informed consent (including impaired judgement, communication barriers)
- •Contraindication against bronchoscopy (e.g. co-morbidities)
- •INR > 2 or Thrombocytes < 50000
- •Double antiplatelet drugs (e.g. ASS and Clopidogrel) within 7 days before biopsy
- •Anticoagulation with NOAK within 48 hours before biopsy
- •Moderate or severe pulmonary hypertension (mPAP > 30 mmHg, RV/RA >30 mmHg)
结局指标
主要结局
diagnostic yield
时间窗: up to 1 month
To investigate the diagnostic yield of two different transbronchial lung biopsy techniques (forceps and cryobiopsy) for diagnosis of acute cellular rejection in lung transplant recipients.
次要结局
- % of patients with treatment alteration due to the biopsy result(up to 1 month)
- Incidence of treatment-emergent adverse events as assessed by bleeding events(up to 1 week)
- Incidence of treatment-emergent adverse events as assessed by pneumothorax rate(up to 1 week)
- interobserver agreement between 3 pathologists(up to 3 months)
研究者
Carolin Steinack
principal investigator
University of Zurich