Identification Of The Predictive Angiographic And Computed Tomographic (CT) Criteria Of The Success Of The Thromboendarterectomy In Chronic Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 249
- 试验地点
- 4
- 主要终点
- surgical effectiveness evaluated by the death or failure rate.
研究概览
简要总结
In order to improve effectiveness of the surgical operation thanks to a reduction in the rate of failure, this study will allow us to identify predictive angiographic and CT finding of surgical failure, starting from standardized reading grids, in order to have a better selection of the operable patients.
详细描述
Chronic thromboembolic pulmonary hypertension(CTEPH) is caused by obstruction of the large pulmonary arteries by acute and recurrent pulmonary emboli, and organization of these blood clots. ANTOINE BECLERE respiratory unit, in partnership with the MARIE LANNELONGUE hospital thoracic and vascular surgery departments was designated recently as reference national centre for pulmonary hypertension and represents the only French structure for evaluation of CTEPH with 150 patients addressed each year.If the disease is proximately located, CTEPH can be cured surgically through a complex surgical procedure performed under Hypothermia and total circulatory arrest. In spite of multidisciplinary meeting deciding the operability of each case the rate of failure is approximately of 15% (9% of operative mortality rate and 6% of technical failure).
The aim of this study is to identify predictive angiographic and CT findings of success, by allowing a better selection of operable patients.
It would be possible to improve the effectiveness of the surgical treatment and reduce the rate failure from 15% to 7 % or even 5 %.
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
- Single (Outcomes Assessor)
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
- •Patients addressed to the reference centre of pulmonary hypertension for a suspected CPC-PE
- •Achieving an assessment prior to the operation, including:1) Right cardiac catheterization confirming HTP with a mean pulmonary arterial pressure> 25 mm Hg at rest; 2) Echography and Doppler of the lower limbs in search of phlebitis sequela; 3) Pulmonary scintigraphy with 6 views in ventilation and perfusion; 4) Digital pulmonary angiography; 5) A 64 detector pulmonary computed tomography; 6) Having read the briefing note and given their agreement.
- •Exclusion criteria:
- •Refusal examinations .
- •Patient for which one method is contraindicated
- •Patient considered not operable by the staff
- •Life expectancy of less than 3 months
- •Geographical distance for the clinical follow-up at 3 months
- •Renal insufficiency (creatinine clearance <30 mL / min)
- •Proven allergy to iodinated contrast agents
- •Pregnant woman.
排除标准
- 未提供
结局指标
主要结局
surgical effectiveness evaluated by the death or failure rate.
时间窗: 6 months
次要结局
- surgical effectiveness evaluated by the death or failure rate.(3 months)
- Check that none of the patients considered unresectable on data from staff was declared operable with the criteria predictive success of imaging examinations.(before surgery)
- Determine the interest of pulmonary angiography in the operability decision compared first to Multi detector AngioCT alone with standardized analyze and then with the both exams.(before surgery)
- Determine the incidence of adverse events associated with each of these two exams or their combination.(3 and 6 months after surgery)
- Check-inter-observer reproducibility of standardized reading grids of pulmonary angiography and MD-AngioCT(Before surgery)