Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00018525
Status:
COMPLETED
Last Update Posted:
2009-01-21
First Post:
2001-07-03
Brief Title:
Lung Volume Reductions Surgery LVRS Study
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Effects of Lung Volume Reduction Surgery in the Treatment of Severe Emphysema
Status:
COMPLETED
Status Verified Date:
2004-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main objectives of this study are to see if a type of lung surgery known as lung reduction surgery in addition to standard medical treatment improves the quality of life lung function and reduces the high mortality associated with severe emphysema when compared to standard medical treatment alone Another goal of this study is to better identify the patients most likely to benefit from this surgical treatment The information obtained in this study is important because lung reduction surgery is being done in several centers around the country but its long term benefits if any over standard medical treatment are not known
Detailed Description:
Chronic obstructive pulmonary disease is a major cause of mortality and morbidity in the US Although medical therapy may delay disability and death there has been no definitive therapy to improve pulmonary function in these patients The resection of emphysematous lung parenchyma lung volume reduction surgery LVRS has been reported in uncontrolled studies in highly selected emphysema patients to substantially improve parameters of pulmonary function dyspnea and quality of life Numerous case series have reported significant short-term benefits Current LVRS data regarding outcomes is limited by study design lacking parallel control groups and lack of long term data
The main objectives of this proposal are 1 To study the effects of LVRS in addition to maximal medical therapy when compared to maximal medical therapy alone in terms of improvement of physiology and quality of life 2 To better define preoperative selection criteria to determine which patients would benefit from this surgical intervention To accomplish these objectives patients who meet clinical criteria and complete a pulmonary rehabilitation-program will be randomized into 2 groups 1 Continuing optimal medical care or 2 bilateral LVRS via median sternotomy in addition to medical therapy
The Houston Veterans Affairs Medical Center is currently performing LVRS under a protocol supported by Merit Review funding 1996-200O Effects of lung volume reduction surgery in the treatment of severe emphysema in selected patients with severe emphysema This controlled study is designed to determine patient selection criteria as well as both the short and long term benefits of operated and non-operated patients with severe emphysema receiving maximal medical therapy Given the strict selection criteria and unexpectedly high survival in both treatment groups to date it is unlikely in a study of this size that survival differences will be detected
In 1997 the National Heart Lung and Blood Institute and Health Care Financing Administration organized a national registry and a controlled multicenter clinical trial to compare bilateral LVRS to maximal medical treatment NETT National Emphysema Treatment Trial
Both our on-going LVRS study and the NETT have been hindered by an underestimation of the difficulty in recruiting patients who qualify for this invasive study Both studies have evaluatedrecruited to date approximately 50 of the projected number of subjects required to achieve statistical power to draw significant clinical conclusions In fact the NIH is investing additional funds in the national marketing of the NETT and LVRS We believe that this national marketing effort as well as changes and enhancement of local recruiting strategies will allow us to enroll adequate patients for study completion This controlled clinical trial will provide data to address crucial clinical and potential economic implications of this surgical intervention in patients with severe emphysema
The main objectives of this proposal are 1 To study the effects of LVRS in addition to maximal medical therapy when compared to maximal medical therapy alone in terms of improvement of physiology and quality of life 2 To better define preoperative selection criteria to determine which patients would benefit from this surgical intervention To accomplish these objectives patients who meet clinical criteria and complete a pulmonary rehabilitation-program will be randomized into 2 groups 1 Continuing optimal medical care or 2 bilateral LVRS via median sternotomy in addition to medical therapy
The Houston Veterans Affairs Medical Center is currently performing LVRS under a protocol supported by Merit Review funding 1996-200O Effects of lung volume reduction surgery in the treatment of severe emphysema in selected patients with severe emphysema This controlled study is designed to determine patient selection criteria as well as both the short and long term benefits of operated and non-operated patients with severe emphysema receiving maximal medical therapy Given the strict selection criteria and unexpectedly high survival in both treatment groups to date it is unlikely in a study of this size that survival differences will be detected
In 1997 the National Heart Lung and Blood Institute and Health Care Financing Administration organized a national registry and a controlled multicenter clinical trial to compare bilateral LVRS to maximal medical treatment NETT National Emphysema Treatment Trial
Both our on-going LVRS study and the NETT have been hindered by an underestimation of the difficulty in recruiting patients who qualify for this invasive study Both studies have evaluatedrecruited to date approximately 50 of the projected number of subjects required to achieve statistical power to draw significant clinical conclusions In fact the NIH is investing additional funds in the national marketing of the NETT and LVRS We believe that this national marketing effort as well as changes and enhancement of local recruiting strategies will allow us to enroll adequate patients for study completion This controlled clinical trial will provide data to address crucial clinical and potential economic implications of this surgical intervention in patients with severe emphysema
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None