Track topics on Twitter Track topics that are important to you
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.
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 evaluated/recruited 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Primary Purpose: Treatment
Lung Volume Reduction Surgery
Veterans Affairs Medical Center
Department of Veterans Affairs
Published on BioPortfolio: 2014-07-23T21:55:53-0400
The purpose of this study is to assess the efficacy of a new treatment algorithm for bronchoscopic lung volume reduction (BLVR) in patients with emphysema based on the information of emphy...
The purpose of this study it to evaluate the efficacy and safety of the 20 mL BLVR System in patients with advanced upper lobe predominant emphysema.
The purpose of this study is to determine whether the Aeris Bronchoscopic Lung Volume Reduction (BLVR) System is safe in patients with advanced emphysema.
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 pat...
The objective of this study is to evaluate the safety and effectiveness of the RePneu Lung Volume Reduction Coil (LVRC) in patients with Alpha-1-Antitrypsin deficiency (AATD) caused emphys...
Pulmonary hypertension (PH) is considered a contraindication for lung volume reduction surgery (LVRS). Because, it has been reported that endobronchial lung volume reduction may have a beneficial effe...
Lung volume reduction surgery (LVRS) and lung transplantation (LTx) are the treatments of choice in selected patients with end-stage emphysema. Recently, the history of LVRS has been questioned due to...
Chronic obstructive pulmonary disease (COPD) has no curative treatment, and in moderate to advanced stages, functional parameters and quality of life are affected. Lung volume reduction improves respi...
Lung volume reduction surgery (LVRS) has been proven to be a successful procedure and can be performed with low mortality when defined selection criteria are met. We hypothesized good outcome and low ...
Emphysema is one of the most common lung diseases in HIV+ individuals. The pathogenesis of HIV-associated emphysema remains unclear; however, radiographic distribution and earlier age of presentation ...
A lung with reduced markings on its chest radiograph and increased areas of transradiancy (hyperlucency). A hyperlucent lung is usually associated with pulmonary emphysema or PNEUMOTHORAX.
The lung volume at which the dependent lung zones cease to ventilate presumably as a result of airway closure.
The capability of the LUNGS to distend under pressure as measured by pulmonary volume change per unit pressure change. While not a complete description of the pressure-volume properties of the lung, it is nevertheless useful in practice as a measure of the comparative stiffness of the lung. (From Best & Taylor's Physiological Basis of Medical Practice, 12th ed, p562)
The volume of air contained in the lungs at the end of a maximal inspiration. It is the equivalent to each of the following sums: VITAL CAPACITY plus RESIDUAL VOLUME; INSPIRATORY CAPACITY plus FUNCTIONAL RESIDUAL CAPACITY; TIDAL VOLUME plus INSPIRATORY RESERVE VOLUME plus functional residual capacity; or tidal volume plus inspiratory reserve volume plus EXPIRATORY RESERVE VOLUME plus residual volume.
Measurement of the volume of gas in the lungs, including that which is trapped in poorly communicating air spaces. It is of particular use in chronic obstructive pulmonary disease and emphysema. (Segen, Dictionary of Modern Medicine, 1992)
Pulmonary relating to or associated with the lungs eg Asthma, chronic bronchitis, emphysema, COPD, Cystic Fibrosis, Influenza, Lung Cancer, Pneumonia, Pulmonary Arterial Hypertension, Sleep Disorders etc Follow and track Lung Cancer News ...
COPD (chronic obstructive pulmonary disease)
COPD (chronic obstructive pulmonary disease) is used for a number of conditions including chronic bronchitis and emphysema, which all lead to the airways in the lungs becoming damaged and thus narrower, making inhalation and exhalation harder...