Contribution of Confocal Microscopy in the Diagnosis of Acute Cell Rejection ACR in Lung Transplantation: Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Determine ability of the operator
研究概览
简要总结
Acute cell rejection is a common complication of lung transplantation. The pathological diagnosis is based on the performance of transbronchial biopsies which are associated with a significant risk of potentially severe pneumothorax and hemoptysis. Confocal microscopy performed during bronchial endoscopy provides real-time images of the lungs on a microscopic scale. Thus, it is possible to visualize the alveoli, capillaries and intra-alveolar inflammatory cells. So far, work on the subject has only investigated the ability of this technique to determine the presence of acute cell rejection on post-fibroscopy analysis. Our hypothesis is that the absence of airway inflammation seen during the procedure by confocal microscopy is able to rule out the diagnosis of ACR and avoid the performance of transbronchial biopsies. Our job is to first assess the feasibility of the per-procedure evaluation and determine a decision algorithm. If the result is conclusive, a larger study will be carried out to assess the negative predictive value of this approach for the diagnosis of acute cell rejection.
详细描述
During the patient's usual follow-up, if an ACR is suspected and it is decided to perform an endoscopy with transbronchial biopsies, the protocol is presented to the patient by the doctor in charge. If the patient agrees to participate in the study, consent is obtained. Collection on arrival of the patient's sex, age, weight, height, respiratory background leading to the patient's lung transplant.
According to the department's protocol: carrying out functional respiratory tests, a biological assessment (CBC, hemostasis and CRP) and a chest x-ray prior to the procedure except if there is another chest imaging dating less than 24 hours testifying to the absence of pneumothorax. Premedication with hydroxyzine, insertion of a peripheral venous route, verification of the patient's identity, anticoagulant or anti-aggregating treatment and potential allergy.
The fibroscopy is carried out according to the usual procedure of the service, namely: realization of 1 to 2 mg of hypnovel intravenously depending on the patient's tolerance, introduction of the fiberscope preferably via the nasal route, if impossible or contraindicated, the oral route is possible with the use of a bite block to protect the fiberscope. Visualization of the mobility of the vocal cords, trachea, carina and right and left bronchial tree up to the segmental level. Identification of the quality of the sutures and the possible presence of bronchial stenosis. Realization of a bronchial trap with bacteriological and mycological analysis. Performing a bronchoalveolar lavage (90cc of physiological serum, preferably in the middle lobe) with anatomopathological, virological, bacteriological, mycological and mycobacteriological analysis.
At this stage, the confocal microscopy procedure begins:
Taking pictures for post-procedure analysis in 4 different territories. For each territory, the investigator need to get a snapshot of a vascular structure and a snapshot of an alveolus.
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
- •Follow-up by the Nantes University Hospital team for a lung transplant
- •Having given their consent
- •Clinical suspicion of acute cellular rejection OR systematic fibroscopy post transplantation to screen for acute asymptomatic rejection
排除标准
- •Minor or adult patient under guardianship and protected person
- •FEV1 <40% of theoretical at the time of inclusion
- •Bleeding disorder
- •Pneumothorax existing before the performance of the fibroscopy
- •Active smoking less than 1 year old
结局指标
主要结局
Determine ability of the operator
时间窗: 1 day
The main objective of this study is to determine the ability of the operator to obtain and interpret confocal microscopy images per procedure. analyzes in real time the images provided by the confocal microscopy probe. the operator determines the presence of intra-alveolar inflammatory cells and evaluates the vessel wall. On the basis of this per-procedure analysis, if the operator considers the interpretation possible, he declares whether he concludes that the presence of pulmonary inflammation is consistent with the diagnosis of rejection.
次要结局
- Correlation confocal microscopy and proven infection(1 day)
- Adverse effects(1 day)
- Correlation inter operator(1 day)
- ability of confocal microscopy to eliminate acute cellular rejection(1 day)