Exploration of the Pleural Cavity Using a fleXible endoscoPe Under Two-Lung ventilatiOn With contRollEd Capnothorax
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 主要终点
- Completeness of the pleural cavity exploration using the flexible endoscope
研究概览
简要总结
EXPLORE is a first-in-human study of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
详细描述
Thoracoscopy is usually performed either with rigid thoracoscopes, or with flexible bronchoscopes. The latter is less invasive and less expensive, but flexible bronchoscopes are difficult to manipulate within the pleural cavity and do not provide an adequate orientation within the pleural space. It is therefore associated with a lower diagnostic yield than thoracoscopy with rigid thoracoscopes. On the other hand, rigid thoracoscopes are associated with more pain, a higher cost, and usually require one-lung ventilation. Gastro-intestinal endoscopes allow a better orientation than bronchoscopes in cavities, and have wider operative channels. The EXPLORE study investigates the feasibility and safety of single port transdiaphragmatic thoracoscopy using a flexible gastro-intestinal endoscope under two-lung ventilation with controlled capnothorax.
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
- •Diagnosis of pleural effusion affirmed by chest radiography,
- •Indication thoracoscopy, asked by the pulmonologist or thoracic surgeon for diagnostic investigation and / or pleural symphysis
- •Inpatient or outpatient,
- •Women of childbearing age having an effective contraceptive coverage (combined oral contraceptives or intrauterine device or tubal ligation); a negative pregnancy test should be obtained,
- •For postmenopausal women, menopause confirmation of diagnosis,
排除标准
- •Pleural effusion compression,
- •Pleural effusion infected or suspected of infection,
- •Febrile patient (> 38 ° C)
- •Parapneumonic effusion
- •Immunosuppression (eg, neutropenia <1G / L, immunosuppressive therapy, ...)
- •Portage known multidrug-resistant germ or S. aureus resistant to methicillin,
- •Clinical suspicion of tuberculosis,
- •Patients who have already been treated by pleurodesis,
- •Contraindication to general anesthesia,
- •Contraindication of prophylactic antibiotics,
- •Contraindication to pleurodesis agent
- •Increased bleeding risk,
- •No one deprived of liberty by an administrative or judicial decision or protected adult subject (under guardianship)
- •Pregnant or breastfeeding women.
研究组 & 干预措施
Thoracoscopy
- experimental intervention (flexible video endoscope)
- reference procedure (video-rigid thoracoscope)
干预措施: flexible video endoscope (Device)
Thoracoscopy
- experimental intervention (flexible video endoscope)
- reference procedure (video-rigid thoracoscope)
干预措施: video-rigid thoracoscope (Device)
结局指标
主要结局
Completeness of the pleural cavity exploration using the flexible endoscope
时间窗: at 0 hours
Two independent experts will visualize the video-recordings of the intervention and evaluate the completeness of the exploration using a standardized score.
次要结局
- Diagnostic yield of biopsies performed with the flexible endoscope(Day 1)
- Outcome of a complication(1 month)
- Results of the microbiological analysis of samples collected on the endoscope seven days before the intervention(Day -7 : 7 days before the intervention)
- Results of the microbiological analysis of samples collected on the endoscope the day of the intervention(at 0 hours)
- Completeness of the pleural cavity exploration using the standard three-ports thoracoscopy with one-lung ventilation(at 0 hours)
- Outcome of a complication(at 0 hours)
- Outcome of a complication(at 4 hours)
- Outcome of a complication(Day 7)