Clinical Trial: The Utility of Radiotherapy in the Management of Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: The Utility of External Beam Radiotherapy for Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases in Patients Who Are Refractory to Medical Management and
Brief Summary: 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 emergency. Haemoptysis can be life-threatening either as a result of compromised gas exchange or because of circulatory collapse secondary to acute blood loss. Haemodynamic and ventilatory support, followed by bronchial artery embolisation (BAE) as a bridge to potentially curative treatment such as lung resection, remains the standard of care. Often patients do not qualify for surgical intervention and BAE is, at best, a temporary solution. External beam radiotherapy (EBRT) may be an alternative, curative intervention in the management of haemoptysis in patients with no alternative options. There is a paucity of studies reporting the use of EBRT in patients without malignancy and with regards to specific doses of EBRT. This pilot study aims to explore the potential of varying doses of EBRT in the management of massive haemoptysis.
Detailed Summary:
Currently the best curative treatment of massive haemoptysis is surgical resection of the affected portion of lung. For patients who do not qualify for surgery, there are few alternative interventions, most of which only provide a temporary solution.
Surgical resection of the diseased areas, which offers the possibility of cure, is best performed as an elective procedure. It carries a not insignificant mortality, with reports varying between 1% and 50%. Unfortunately, many patients admitted to Tygerberg Academic Hospital, are not candidates for either elective or emergency surgical resection. The most common reasons for inoperability are: irresectable disease (i.e. damage to the lungs is bilateral and too extensive to allow resection, or the site of bleeding is not known); or severely reduced cardiopulmonary reserves secondary to extensive pre-existing lung damage, making lung resection surgery impossible due to excessively high mortality risk.
Repeat BAE (as a palliative measure in inoperable cases) is not always technically feasible and does not always lead to cessation of the bleeding. Additionally long term recurrence rates following BAE are variable estimated at between 18-42%, and carries a high mortality.
A significant number of patients with massive haemoptysis do not qualify for either surgery or BAE, thus rendering them without treatment option, save palliation with long-term opiates. Their fate is that of recurrent haemoptysis and a high associated mortality. Endobronchial occluding devices have been considered, however their high cost and required expertise prohibits their extensive use.
A novel treatment of this condition potentially is external beam radiotherapy (EBRT). A case report of five patients has docume
Sponsor: University of Stellenbosch
Current Primary Outcome: Composite end-point of time to recurrent life-threatening haemoptysis, or death [ Time Frame: 1 year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Six minute walk test [ Time Frame: 1 year ]Improvement from baseline
- Time to massive haemoptysis (>200mL per day) [ Time Frame: 1 year ]
- Fev1/FVC [ Time Frame: 1 year ]Improvement from baseline
- Total lung capacity (TLC) Total lung capacity (TLC) [ Time Frame: 1 year ]Improvement from baseline
- Diffusion capacity (DLCO) Total lung capacity (TLC) [ Time Frame: 1 year ]Improvement from baseline
- Radiological change in volume (maximum diameters in three planes) [ Time Frame: 1 year ]Performed by two radiologists to determine the radiological resolution of aspergillomata
- Number of complications associated with Radiotherapy [ Time Frame: 1 year ]nausea, skin changes, pulmonary infection, pain etc.
Original Secondary Outcome: Same as current
Information By: University of Stellenbosch
Dates:
Date Received: June 23, 2016
Date Started: June 2016
Date Completion: June 2017
Last Updated: August 19, 2016
Last Verified: August 2016
