Faculty Opinions recommendation of Bronchoscopic lung volume reduction with endobronchial valves for patients with heterogeneous emphysema and intact interlobar fissures (the BeLieVeR-HIFi study): a randomised controlled trial.

2017 ◽  
Author(s):  
Ravi Kalhan ◽  
Sharon R Rosenberg
Keyword(s):  
Randomised Controlled Trial ◽  
Lung Volume ◽  
Controlled Trial ◽  
Volume Reduction ◽  
Lung Volume Reduction ◽  
Randomised Controlled

scholarly journals CELEB trial: Comparative Effectiveness of Lung volume reduction surgery for Emphysema and Bronchoscopic lung volume reduction with valve placement: a protocol for a randomised controlled trial

BMJ Open ◽  
2018 ◽  
Vol 8 (10) ◽  
pp. e021368 ◽  
Author(s):  
Sara Buttery ◽  
Samuel V Kemp ◽  
Pallav L Shah ◽  
David Waller ◽  
Simon Jordan ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Exercise Capacity ◽  
Lung Volume ◽  
Clinical Decision Making ◽  
Controlled Trial ◽  
Airflow Obstruction ◽  
Volume Reduction ◽  
Lung Volume Reduction Surgery ◽  
Lung Volume Reduction ◽  
Randomised Controlled

IntroductionAlthough lung volume reduction surgery and bronchoscopic lung volume reduction with endobronchial valves have both been shown to improve lung function, exercise capacity and quality of life in appropriately selected patients with emphysema, there are no direct comparison data between the two procedures to inform clinical decision-making.Methods and analysisWe describe the protocol of the CELEB study, a randomised controlled trial which will compare outcomes at 1 year between the two procedures, using a composite disease severity measure, the iBODE score, which includes body mass index, airflow obstruction, dyspnoeaand exercise capacity (incremental shuttle walk test).Ethics and disseminationEthical approval to conduct the study has been obtained from the Fulham Research Ethics Committee, London (16/LO/0286). The outcome of this trial will provide information to guide treatment choices in this population and will be presented at national and international meetings and published in peer-reviewed journals. We will also disseminate the main results to all participants in a letter.Trial registration numberISRCTN19684749; Pre-results.

scholarly journals Endobronchial valves for severe emphysema

2019 ◽  
Vol 28 (152) ◽  
pp. 180121 ◽  
Author(s):  
Jorine E. Hartman ◽  
Lowie E.G.W. Vanfleteren ◽  
Eva M. van Rikxoort ◽  
Karin Klooster ◽  
Dirk-Jan Slebos
Keyword(s):  
Lung Volume ◽  
Treatment Guidelines ◽  
Routine Care ◽  
Volume Reduction ◽  
Future Research ◽  
Lung Volume Reduction ◽  
Regular Treatment ◽  
Number Of Patients ◽  
Predictive Risk ◽  
Randomised Controlled

The results of the randomised controlled trials investigating the bronchoscopic lung volume reduction treatment using endobronchial valves (EBV) are promising, and have led to their inclusion in treatment guidelines, US Food and Drug Administration approval and inclusion in routine care in an increasing number of countries. The one-way valve treatment has advanced and is now a regular treatment option. However, this new phase will lead to new challenges in terms of implementation. We believe that key issues in future research concern advanced patient selection, improved methods for target lobe selection, increased knowledge on the predictive risk of a pneumothorax, positioning of pulmonary rehabilitation in conjunction with the EBV treatment, the positioning of lung volume reduction surgeryversusEBV treatment, and the long-term efficacy, adverse events, impact on exacerbations and hospitalisations, costs and survival. Hopefully, the increasing number of patients treated, the setup of (inter)national registries and future research efforts will further optimise all aspects of this treatment.

scholarly journals Equipoise and the Ethics of the Canadian Lung Volume Reduction Surgery Trial study: Should There Be a Randomized, Controlled Trial to Evaluate Lung Volume Reduction Surgery?

2000 ◽  
Vol 7 (4) ◽  
pp. 329-332 ◽  
Author(s):  
John D Miller ◽  
Michael D Coughlin ◽  
Lori Edey ◽  
Patricia Miller ◽  
Yasmin Sivji
Keyword(s):  
Randomized Controlled Trial ◽  
Lung Volume ◽  
Controlled Trial ◽  
Volume Reduction ◽  
Three Dimensions ◽  
Clinical Equipoise ◽  
Lung Volume Reduction Surgery ◽  
Lung Volume Reduction ◽  
Randomized Controlled ◽  
Surgery Trial

The physical improvement is so great following lung volume reduction surgery that there is growing opinion that a randomized, controlled trial is unnecessary. A randomized, controlled trial, it is argued, would deprive those patients randomly assigned to the nonsurgical treatment arm the 'benefit' of lung volume reduction surgery. Entering a trial in which one arm leads to a surgical intervention and the other to best medical management also poses a variety of ethical difficulties. If one is to be offered surgery, there must be perceived benefit because the physician has an obligation to offer the best possible treatment for his or her patient. If a patient agrees to have surgery, the expectation is that surgery would help. Thus, a patient randomly assigned to the medical arm of a trial may easily believe that he or she is being deprived of surgery that may help them. This paper illustrates this dilemma using the Canadian Lung Volume Reduction Surgery Trial. The authors discuss the concept of 'equipoise' in three dimensions, adding community equipoise to theoretical equipoise and clinical equipoise earlier described by Freedman. The paper concludes that the Canadian Lung Volume Reduction Surgery Trial needs to continue because of the clinical equipoise that drives it.

Interventions In Asthma and COPD

2019 ◽  
Vol 76 (6) ◽  
pp. 328-336
Author(s):  
Neha P. Mandovra ◽  
Jörg D. Leuppi ◽  
Felix J. F. Herth ◽  
Prashant N. Chhajed
Keyword(s):  
Severe Asthma ◽  
Lung Volume ◽  
Volume Reduction ◽  
Significant Morbidity ◽  
Lung Volume Reduction ◽  
Bronchial Thermoplasty ◽  
Clinical Trial Evidence ◽  
Clinical Benefits ◽  
Randomised Controlled ◽  
Prolonged Hospital

Abstract. Advanced emphysema and asthma constitute major health burden worldwide and are associated with significant morbidity and mortality. Pharmacological options are limited. Researches are being carried out aiming to modify the natural course of both the diseases. Lung volume reduction surgeries are performed in advanced emphysema but are associated with significant morbidity and prolonged hospital stay. Various minimally invasive bronchoscopic methods have been developed with the goal of achieving clinical benefits of volume reduction surgery but lower complications. Bronchial thermoplasty is a bronchoscopic method of delivering controlled heat in the airways to reduce airway smooth muscle mass, thereby reducing bronchoconstriction in patients with severe asthma who remain uncontrolled despite optimal medical therapy. Various randomised controlled trials have been performed to evaluate the safety and efficacy of various endoscopic treatments like valves, coils, use of sclerosants and targeted lung denervation for severe emphysema and bronchial thermoplasty in severe asthma. The current review summaries the clinical trial evidence available for lung volume reduction in emphysema and thermoplasty in asthma and provide guidance for optimal patient selection for various therapies available.

Sign in / Sign up

Export Citation Format

Share Document