Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00000606
Status:
COMPLETED
Last Update Posted:
2016-04-14
First Post:
1999-10-27
Brief Title:
National Emphysema Treatment Trial NETT
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-04
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:
To evaluate the long term efficacy morbidity and mortality associated with medical therapy with lung volume reduction surgery LVRS as compared to medical therapy alone and to define patient selection criteria The trial conducted in conjunction with a patient registry is supported by the NHLBI the Centers for Medicare and Medicaid Services CMS and the Agency for Healthcare Research and Quality AHRQ
Detailed Description:
BACKGROUND
LVRS is intended primarily for those patients whose chronic obstructive pulmonary disease COPD is predominantly emphysema Emphysema is characterized anatomically by abnormal persistent enlargement of the airspaces distal to the terminal bronchioles accompanied by the destruction of the airspace walls and without obvious fibrosis The loss of the lung architecture leads to compressible peripheral airways that close at higher than normal lung volumes early airway closure The increased compliance and the air trapping from early closure leads to hyperinflation of the lung over distention of the chest wall a flattened disadvantaged diaphragm and ventilation-perfusion mismatch In the 1950s and 1960s Dr Otto Brantigan theorized that surgical excision of multiple wedges of lung would reduce lung volumes thereby restoring the outward elastic pull on the small airways and reduce airway obstruction Dr Brantigan reported that the surgical excision of lung tissue resulted in significant clinical improvement in some cases but mortality was high With little objective data and high mortality the procedure did not gain widespread acceptance
The experience that diaphragmatic and chest wall function could be restored in emphysema with lung transplantation renewed interest in Dr Brantigans work Improvements in surgical technique have opened the possibility of performing surgical excisions of lung tissue Recent reports on LVRS have shown improvements in FEV1 FVC TLC RV and dyspnea and quality of life assessments
These reports generated enormous excitement among patients and their doctors Many centers around the country started performing LVRS with the result that hundreds of patients had the procedure despite the preliminary nature of the results the lack of rigorous patient selection criteria and the lack of information on long term outcome Basic questions remain such as which patient should have the surgery what protocol should be followed what physiological tests should be obtained and what is the long term efficacy of the technique on morbidity mortality and quality of life The mechanisms of benefit and the full cardiopulmonary consequences are unknown
The concept for the trial originated in the NHLBI Workshop on Evaluation and Research in Lung Volume Reduction Surgery The initiative was reviewed and approved at the May 1996 National Heart Lung and Blood Advisory Council meeting The Requests for Proposals were released in June 1996
DESIGN NARRATIVE
In the trial 1218 eligible patients were randomized to receive either medical therapy 610 or medical therapy with LVRS608 LVRS was performed by median sternotomy or video-assisted thorascopic surgery VATS Centers randomized their patients to either a medical therapy alone versus medical therapy with LVRS by median sternotomy b medical therapy alone versus medical therapy with LVRS by VATS or c medical therapy alone versus medical therapy with LVRS by median sternotomy versus medical therapy with LVRS by bilateral VATS Medical therapy included pulmonary rehabilitation and education Direct comparisons of the two surgical techniques were possible only at the centers that performed both techniques All arms included intensive pulmonary rehabilitation The primary endpoints were survival and functional improvement as assessed by maximum workload Secondary endpoints included morbidity improvement in pulmonary function quality of life and performance of activities of daily living Follow-up exams including history physical exams pulmonary function tests exercise tests and quality of life assessments occurred after pre-operative rehabilitation and six and twelve months after surgery and every twelve months thereafter Recruitment ended July 31 2002 and follow-up ended in December 2002
LVRS is intended primarily for those patients whose chronic obstructive pulmonary disease COPD is predominantly emphysema Emphysema is characterized anatomically by abnormal persistent enlargement of the airspaces distal to the terminal bronchioles accompanied by the destruction of the airspace walls and without obvious fibrosis The loss of the lung architecture leads to compressible peripheral airways that close at higher than normal lung volumes early airway closure The increased compliance and the air trapping from early closure leads to hyperinflation of the lung over distention of the chest wall a flattened disadvantaged diaphragm and ventilation-perfusion mismatch In the 1950s and 1960s Dr Otto Brantigan theorized that surgical excision of multiple wedges of lung would reduce lung volumes thereby restoring the outward elastic pull on the small airways and reduce airway obstruction Dr Brantigan reported that the surgical excision of lung tissue resulted in significant clinical improvement in some cases but mortality was high With little objective data and high mortality the procedure did not gain widespread acceptance
The experience that diaphragmatic and chest wall function could be restored in emphysema with lung transplantation renewed interest in Dr Brantigans work Improvements in surgical technique have opened the possibility of performing surgical excisions of lung tissue Recent reports on LVRS have shown improvements in FEV1 FVC TLC RV and dyspnea and quality of life assessments
These reports generated enormous excitement among patients and their doctors Many centers around the country started performing LVRS with the result that hundreds of patients had the procedure despite the preliminary nature of the results the lack of rigorous patient selection criteria and the lack of information on long term outcome Basic questions remain such as which patient should have the surgery what protocol should be followed what physiological tests should be obtained and what is the long term efficacy of the technique on morbidity mortality and quality of life The mechanisms of benefit and the full cardiopulmonary consequences are unknown
The concept for the trial originated in the NHLBI Workshop on Evaluation and Research in Lung Volume Reduction Surgery The initiative was reviewed and approved at the May 1996 National Heart Lung and Blood Advisory Council meeting The Requests for Proposals were released in June 1996
DESIGN NARRATIVE
In the trial 1218 eligible patients were randomized to receive either medical therapy 610 or medical therapy with LVRS608 LVRS was performed by median sternotomy or video-assisted thorascopic surgery VATS Centers randomized their patients to either a medical therapy alone versus medical therapy with LVRS by median sternotomy b medical therapy alone versus medical therapy with LVRS by VATS or c medical therapy alone versus medical therapy with LVRS by median sternotomy versus medical therapy with LVRS by bilateral VATS Medical therapy included pulmonary rehabilitation and education Direct comparisons of the two surgical techniques were possible only at the centers that performed both techniques All arms included intensive pulmonary rehabilitation The primary endpoints were survival and functional improvement as assessed by maximum workload Secondary endpoints included morbidity improvement in pulmonary function quality of life and performance of activities of daily living Follow-up exams including history physical exams pulmonary function tests exercise tests and quality of life assessments occurred after pre-operative rehabilitation and six and twelve months after surgery and every twelve months thereafter Recruitment ended July 31 2002 and follow-up ended in December 2002
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: