Advertisement

Topics

Endobronchial Valves in Inoperable Patients With Haemoptysis

2016-06-28 21:23:21 | BioPortfolio

Summary

Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis. Various treatment options exist such as bronchial artery embolisation (BAE) or surgical resection of the affect lung region. However, BAE is not considered curative as there is often recurrence of haemoptysis. Furthermore, not all patients will be deemed suitable for surgical resection, leaving them with very few treatment options. A possible alternative intervention is the insertion of an endobronchial valve (EBV). It is speculated that blood will collect distal to the one way valve and a thrombus will be formed. There is currently no data describing the use of EBV for the treatment of massive haemoptysis. This RCT aims to explore the use and efficacy of EBV in the management of massive haemoptysis.

Description

Massive haemoptysis commonly occurs in patients who have had tuberculosis. While surgical resection of the affected lung segment can be curative, a large majority of patients may not qualify for surgical intervention for a number of reasons. This leaves them with few options to manage their haemoptysis.

Many patients at Tygerberg Hospital have severely reduced cardiopulmonary reserves secondary to multiple episodes of pulmonary Tuberculosis and often present either a unilateral largely destroyed lung or bilateral disease, which make them unsuitable for surgery. For these unfortunate patients who do not qualify for surgery or repeat BAE, practically no treatment options exist, and a significant proportion die in hospital or after discharge from a recurrent episode of massive haemoptysis. For these patients the only option may be to block the bleeding bronchus (identified by the previous BAE or during bronchoscopy) with a balloon catheter (Fogarty catheter)(Freitag et al, 1994) or placement of haemostatic gauze or gel. All these procedures are, however, of limited benefit. Using a blocking device which could be deployed and left in place permanently or be removed if needed has become a new therapeutic concept. Dutau and colleagues reported the successful use of the endoscopic placement of a silicone Spigot in a 39-year-old-woman with massive haemoptysis which prevented alveolar inundation preceding and during the time of bronchial artery embolisation (Dutau et al, 2006).

Our institution has a long standing experience in massive haemoptysis, clinically and scientifically(van den Heuvel et al, 2007; Gross et al,2009). We evaluate about 80-100 patients with life threatening haemoptysis a year. Furthermore, we were involved in an early emphysema trial using the IBVEBV® (Intra-Bronchial Valve) of Spiration and have, therefore, the necessary experience with the valve implantation technique.

No data are available regarding the potential clinical use of endobronchial valves in patients with recurrence of haemoptysis after BAE in patients who are not candidate for surgery or BAE.

This study aims to investigate the use, therapeutic benefit and safety of IBV Zephyr® valves in inoperable patients with haemoptysis not responding to BAE or in cases where BAE is not considered feasible.

This is a prospective randomised intervention-control study, with patients allocated to either best medical care (control) or endobronchial valve (intervention) groups. The valves will be inserted via flexible bronchoscopy into the affected lung regions. The primary outcome measure is the time to resolution of massive haemoptysis. Secondary outcomes will include physical and lung function and the occurrence of complications resulting from the insertion of the EBV.

Statistical analysis will be performed blinded to patient grouping by a statistician, and both univariate and multivariate analyses will be performed using the appropriate parametric and non-parametric tests. Appropriate tests for categorical data (e.g. Chi-squared test) and continuous data (e.g. Kruskal-Wallis, and ANOVA) will be used. Logistic and linear regression modelling will be used for certain outcomes, and multivariate analysis will be performed using stepwise regression modelling and full modelling where appropriate.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Conditions

Haemoptysis

Intervention

Insertion of endobronchial valve

Status

Not yet recruiting

Source

University of Stellenbosch

Results (where available)

View Results

Links

Published on BioPortfolio: 2016-06-28T21:23:21-0400

Clinical Trials [780 Associated Clinical Trials listed on BioPortfolio]

Two-staged Approach in Positioning Endobronchial Blockers Without Fiberoptic Guidance

The purpose of this study is to find a novel method for placing endobronchial blockers without fiberoptic guidance to provide one-lung isolation during anesthesia for thoracic surgery.

The Utility of Radiotherapy in the Management of Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases

The sequelae of tuberculosis are still the commonest causes of haemoptysis in the developing world, where life-threatening haemoptysis remains a common and not infrequently fatal medical e...

Endobronchial Valve for Emphysema PalliatioN Trial (VENT) Cost-effectiveness Sub-Study

The purpose of the VENT Cost-Effectiveness Sub-Study is to gather healthcare utilization and quality of life information on patients enrolled in the VENT study in order to analyze the rela...

Aortic Root Enlargement in Aortic Valve Replacement

Aortic valve disease is a progressive illness that varies from minor valve thickening lacking obstruction of blood stream to severe calcification and alteration of the valve leading to wea...

Natural History of Melody Valve in the Mitral and Tricuspid Position

The Melody valve has historically been used for pulmonary valve replacements; however it has been more recently used in the mitral and tricuspid positions. This multi-center, retrospective...

PubMed Articles [1664 Associated PubMed Articles listed on BioPortfolio]

Multispacer sequence typing of Coxiella burnetii DNA from removed prosthetic heart valve material discloses first human case of infective endocarditis caused by MST_18.

In Denmark, Q fever was previously considered a rare and imported disease, but recent testing of antibodies in cattle as well as humans has indicated that the infection is widespread. A 76-year old Da...

Mechanisms of recurrent haemoptysis after super-selective bronchial artery coil embolisation: a single-centre retrospective observational study.

In recognition of the significant impairment caused by haemoptysis on a patient's quality of life, bronchial artery embolisation has been introduced worldwide as one of the first-line treatment option...

Aortic Valve-in-Valve in Externally Mounted Bioprosthesis: A Safe Treatment Option for Bioprosthetic Structural Valve Dysfunction.

Aortic valve-in-valve implantation for prosthetic valve dysfunction is a good alternative to reoperative valve replacement. There are some limitations to this approach including the risk of coronary o...

Conversion to thoracotomy during VATS segmentectomy for treatment of symptomatic endobronchial hamartoma.

Most hamartomas are located peripherally in the lung parenchyma and are rarely identified as an endobronchial lesion. Clinically patients with an endobronchial hamartoma are often symptomatic and may ...

Endobronchial Smooth Muscle Tumors: A Series of Five Cases Highlighting Pitfalls in Diagnosis.

Primary endobronchial smooth muscle tumors (SMTs), which are extremely rare, include endobronchial leiomyomas and leiomyosarcomas. Clinically, SMTs present with signs and symptoms of bronchial obstruc...

Medical and Biotech [MESH] Definitions

Widening of a stenosed HEART VALVE by the insertion of a balloon CATHETER into the valve and inflation of the balloon.

A type of heart valve surgery that involves the repair, replacement, or reconstruction of the annulus of the MITRAL VALVE. It includes shortening the circumference of the annulus to improve valve closing capacity and reinforcing the annulus as a step in more complex valve repairs.

A type of heart valve surgery that involves the repair, replacement, or reconstruction of the annuli of HEART VALVES. It includes shortening the circumference of the annulus to improve valve closing capacity and reinforcing the annulus as a step in more complex valve repairs.

Surgical insertion of synthetic material to repair injured or diseased heart valves.

Abnormal protrusion of one or more of the leaflets of TRICUSPID VALVE into the RIGHT ATRIUM during SYSTOLE. This allows the backflow of blood into right atrium leading to TRICUSPID VALVE INSUFFICIENCY; SYSTOLIC MURMURS. Its most common cause is not primary valve abnormality but rather the dilation of the RIGHT VENTRICLE and the tricuspid annulus.

More From BioPortfolio on "Endobronchial Valves in Inoperable Patients With Haemoptysis"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Pulmonary
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 ...

Tuberculosis TB
Tuberculosis (TB) is an infectious disease caused by bacteria belonging to the Mycobacterium tuberculosis complex. Over nine million new cases of TB, and nearly two million deaths from TB, are estimated to occur around the world every year, and new inf...

Surgical treatments
Surgery is a technology consisting of a physical intervention on tissues. All forms of surgery are considered invasive procedures; so-called "noninvasive surgery" usually refers to an excision that does not penetrate the structure being exci...


Searches Linking to this Trial