Research on Comprehensive Management of End-stage Severe Chronic Respiratory Diseases - Study of Transbronchial Cryobiopsy in Monitoring Complications of Lung Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 主要终点
- Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
研究概览
简要总结
The goal of this randomized controlled trial is to compare the diagnostic efficacy and safety of transbronchial cryobiopsy (TBCB) and traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection , so as to establish the evidence-based medical basis for the effectiveness and safety of TBCB for monitoring after lung transplantation, It is expected to provide a better auxiliary examination method for lung transplantation.
The main questions it aims to answer are: (1) Histopathological evaluability of specimens; (2) Safety of TBCB; (3) Size and quality of specimen, and number of attempts to obtain five samples.
Participants will undergo TBCB with 1.1 mm flexible cryoprobe or traditional transbronchial lung biopsy with biopsy forceps.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age among 18-65 years old
- •After unilateral or bilateral lung transplantation, patient with unexplained pulmonary function decline, acute/chronic clinical lung injury or new pulmonary infiltrates
- •or patients requiring monitoring of rejection after lung transplantation
- •The patient should undertake routine preoperative examinations for lung cryobiopsy, including routine blood test, coagulation function, electrocardiogram, and chest CT, and the patients have no contraindications to cryobiopsy
排除标准
- •patients intolerable to undertake lung biopsy due to severe cardiopulmonary insufficiency or being weak
- •The patient is allergic to lidocaine and midazolam
- •The patient has recent active massive hemoptysis, or the proposed biopsy site has a high risk of bleeding, such as bronchial artery penetration or suspected renal cancer lung metastasis
- •Unstable angina, congestive heart failure, severe bronchial asthma or multiple bullae
- •Severe hypertension and arrhythmia, hemodynamic instability and severe respiratory failure (PaO2<60mmHg after oxygen therapy or mechanical ventilation)
- •The patient has coagulation disorder and unable to stop taking anticoagulants, antiplatelet drugs, aspirin or non-steroidal anti-inflammatory drugs before lung biopsy
- •Suspected aortic aneurysm
- •The patient does not agree to participate in this study
- •Participating in other studies within three months and not withdrawing or ending
- •The researchers think that the patient are not suitable for inclusion
结局指标
主要结局
Diagnostic efficacy of transbronchial cryobiopsy versus traditional transbronchial lung biopsy for diagnosing the lung transplantation rejection
时间窗: 7 days after lung biopsy
Diagnostic yield of transbronchial cryobiopsy (TBCB) for diagnosing the lung transplantation rejection, compare with that of traditional transbronchial lung biopsy. The reference standard is the result of Multi-Disciplinary Treatment (MDT).
次要结局
- Incidence of complications(one day, 3 days and 7 days after lung biopsy)
- Sample size(during surgery)
- the number of alveoli in the biopsy sample(7 days after lung biopsy)
- number of attempts to get five samples(during surgery)
- the number of blood vessels in the biopsy sample(7 days after lung biopsy)
- the percentage of the area of lung parenchyma without artifacts in the biopsy sample(7 days after lung biopsy)
研究者
Ting YANG
Principal Investigator
China-Japan Friendship Hospital