Haemoptysis Clinical Trial
Official title:
Endobronchial Valves in Inoperable Patients With Life-threatening Haemoptysis Refractory to Bronchial Artery Embolisation
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.
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) 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.
Our institution has a long standing experience in massive haemoptysis, clinically and
scientifically. 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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT02913365 -
Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis
|
N/A | |
| Recruiting |
NCT02878447 -
The Utility of Radiotherapy in the Management of Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases
|
N/A |