Mini Invasive Probe Based Confocal Laser Endomicroscopy of the Pleura for Malignancies Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Malignant Pleural Infiltration Identification
研究概览
简要总结
Recently, probe based confocal laser endomicroscopy showed to be able to distinguish malignant from benign pleura during medical thoracoscopy. However The clinical usefulness of this new tool remains to be determined.
The investigators believe that pCLE could be part of mini invasive pleural disease management and could be used during thoracentesis in order to increase the diagnostic yield of this procedure. The investigators are starting a prospective trial to recruit patients referred for medical thoracoscopy to the endoscopy unit.
First, the pCLE probe will be introduced through the Boutin's needle or the thoracentesis catheter, just before the thoracoscopy, in order to investigate the pleural pCLE features and to identify or exclude malignant infiltration. Second those features will be compared to the pCLE acquisition obtained during the medical thoracoscopy (the probe is introduced through the working chanel of the thoracoscope), under visual control. In order to compare the invasive and mini invasive acquisition, 10 criteria will be prospectively assessed.Third, These features will be compared to the histological samples performed during thoracoscopy. Finally, the interpretation of different investigators will be compared.
The 10 criteria are presented below:
- Abnormal tissular architecture
No: Correct identification of the previously described normal pleura characteristics Yes: identification of cellular/tissular structures which are not known to correspond to normal pleura (cellular clusters or dark clumps, glands, cells cordons, dysmorphic cells, papillar distribution....) 2. Cellular homogeneity is size, shape and fluorescence, as subjectively assessed by the investigator
yes no 3. Mean cellular size:
Small: < 10µm Moderate: 10 - 20µm Large: > 20µm 4. Cellular density (with reference to the Chia seed sign)
Low (lower than the Chia seed sign) Moderate High 5. Dysplastic vessels:
Yes: (vascular leaks, tortuous or giant vessels) No: no dysplasia 6. Vascular density (on a full optical area)
Low: 0 -2 vessels Moderate: 3 - 4 vessels High: > 4 vessels 7. Organized or anarchic connective fibers
Anarchic: coarse fibers, irregular in shape, without well-defined architecture Organized : regular in shape and direction, well defined architecture. 8. Chia seed sign on a full optical areal
yes No
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Every patient referred to the endoscopy unit for medical thoracoscopy
排除标准
- •Pregnancy
- •Known allergy to the fluorescein
结局指标
主要结局
Malignant Pleural Infiltration Identification
时间窗: one day
Before medical thoracoscopy, the laser endomicroscopy probe will be introduced through the Boutin's needle or the thoracentesis catheter. The pleural probe based confocal laser endomicroscopy acquisition will be assessed by two experienced and unblinded clinicians (aware of the medical history of the patient) during the procedure. The objective is to determine if the preselected criteria are present with significantly different frequencies in malignant adn in benign pleural involvement.
Concordance Between the Mini Invasive Assessment and the Invasive Pleural Assessment.
时间窗: One day
Every (Serious)adverse event will be reported during the intervention or during post intervention surveillance (1 hour post intervention). The feasibility will be assessed by comparing the images from the mini invasive phase with this from the invasive phase.
Pleural Fluid Cytological Analysis
时间窗: one day
Pathological analysis of the collected pleural fluid is compared to the final histological diagnosis of pleural biopsies.
次要结局
未报告次要终点
研究者
Olivier Bonhomme
Head of clinic in pulmonary medicine
University of Liege