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Clinical Trials/NCT02778802
NCT02778802
Unknown
N/A

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

Cairo University1 site in 1 country20 target enrollmentJune 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Pulmonary Hypertension
Sponsor
Cairo University
Enrollment
20
Locations
1
Primary Endpoint
change in mean Pulmonary artery pressure after ELVR
Last Updated
9 years ago

Overview

Brief Summary

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.

Detailed Description

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. Materials and Methods This is Prospective descriptive study on 20 COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema admitted in chest department at Kasr al Ainy Hospital. All patients will be on optimal medical treatment for COPD according to Global Initiative for Chronic Obstructive Lung Disease guidelines \[13\] All patients will be subjected to the following at base line. 1. full history taking. 2. full clinical examination. 3. plain chest x ray. 4. an electrocardiogram, High resolution computed tomography of the chest. 5. Pulmonary function tests and ABG. 6. 6-minute walk test. 7. 2-D echocardiography at rest 8. Right heart catheterization (RHC) 9. Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by 1. Dyspnea score (using mMRC score) 2. 6-minute walk test. 3. ECG At 3rd Month 2-D echocardiography at rest will be done At 6th Month 2-D echocardiography at rest And RHC will be done .

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
May 2017
Last Updated
9 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mostafa Elshazly

Professor of pulmonary Medicine

Cairo University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

change in mean Pulmonary artery pressure after ELVR

Time Frame: 3months, 6monthes

Right heart cathetrization

Secondary Outcomes

  • Dysnea Score(3 months,6months)

Study Sites (1)

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