Clinical Trial: Endobronchial Valves in Inoperable Patients With Haemoptysis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Endobronchial Valves in Inoperable Patients With Life-threatening Haemoptysis Refractory to Bronchial Artery Embolisation

Brief 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.

Detailed Summary:

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.

Same as current

Current Secondary Outcome:

  • Time to recurrence of haemoptysis [ Time Frame: 1 year ]
  • Improvement in exercise performance [ Time Frame: 1 year ]
  • Improvement in lung function [ Time Frame: 1 year ]
  • Recurrence of infection/tuberculsis [ Time Frame: 1 year ]
  • EBV related complications [ Time Frame: 1 year ]


Original Secondary Outcome: Same as current

Information By: University of Stellenbosch

Dates:
Date Received: June 23, 2016
Date Started: August 2016
Date Completion: December 2017
Last Updated: July 4, 2016
Last Verified: July 2016