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临床试验/NCT02778802
NCT02778802Unknown不适用

Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )

Cairo University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
change in mean Pulmonary artery pressure after ELVR

研究概览

简要总结

This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.

Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.

详细描述

Chronic obstructive pulmonary disease (COPD) continues to be a leading cause of morbidity and is currently the third most common cause of mortality worldwide (1).

In most patients with severe COPD, chronic airflow limitation, lung emphysema with parenchymal destruction and the development of air bullae also occur (2-3) Pulmonary hypertension (PH) is a common consequence of COPD, although the actual overall prevalence of PH in COPD remains unclear (4). Among COPD patients who were to undergo lung-volume-reduction surgery or lung transplantation, mild PH was observed in 50.2%, moderate PH in 9.8%, and severe PH in 3.7%(5). While in most COPD patients who develop PH, pulmonary arterial pressure is only mildly or moderately elevated, (6) PH has an independent prognostic impact on survival. (6,7) The therapeutic options for COPD patients with severe emphysema are limited. Lung volume reduction surgery (LVRS) has been performed as treatment in selected cases, but the referral of patients has been severely influenced by the marked perioperative morbidity and mortality [8]. Less invasive techniques have been developed with the aim of improving patients' pulmonary function, symptoms, and quality of life (QoL) [9]. Among them, the one most commonly used is the endoscopic placement of one way endobronchial valves (EBV) [10-12]. So far patients with severe emphysema and established PH have been excluded from LVRS as well as from endoscopic lung volume reduction (ELVR) therapy.

Whether bronchoscopic lung volume reduction in COPD patients with silver nitrate or histoacryl influences the severity of PH in patients with severe emphysema and PH has yet to be elucidated.

This study is designed as a prospective pilot study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.

Secondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema

排除标准

  • Airflow limitation with FEV1 < 20%.
  • Patients not candidate for FOB.

结局指标

主要结局

change in mean Pulmonary artery pressure after ELVR

时间窗: 3months, 6monthes

Right heart cathetrization

次要结局

  • Dysnea Score(3 months,6months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mostafa Elshazly

Professor of pulmonary Medicine

Cairo University

研究点 (1)

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