跳至主要内容
临床试验/NCT02878447
NCT02878447Unknown不适用

The Utility of External Beam Radiotherapy for Haemoptysis Secondary to Aspergillomata and Structural Lung Diseases in Patients Who Are Refractory to Medical Management and Not Surgical Candidates: A Pilot Study

University of Stellenbosch2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Composite end-point of time to recurrent life-threatening haemoptysis, or death

研究概览

简要总结

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.

详细描述

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 documented EBRT in the setting of mycetoma where between 7 and 14Gy was used, with cessation of life threatening haemoptysis. However follow-up was limited to 6 months, and the effects of EBRT in the setting of post-tuberculous structural lung disease without mycetoma is not known. The potential mechanism of the achieved haemostasis was speculated as being the induction of radiation damage to the radiosensitive capillaries, with subsequent inflammatory response, in keeping with previous rat models of lung perfusion following high dose (30Gy) EBRT exposure.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult subjects, 18 years of age and older.
  • Written informed consent provided by patient
  • Current or previously documented admission to hospital with large volume haemoptysis (>200ml); or haemoptysis with haemodynamic compromise (SBP < 100mmHg for 15 minutes) or requiring fluid resuscitation; haemoptysis requiring intubation or deemed life-threatening by attending clinicians.
  • The cause of haemoptysis must be due to severe underlying lung destruction/ bronchiectasis, post-tuberculous lung damage or the presence of an aspergillomata.
  • Primary bronchial artery embolisation not considered technically possible or failed BAE
  • Lung resection not possible because of poor cardiopulmonary reserves (as defined by the current ERS/ESTS clinical guidelines, independently reviewed by a team of consisting of a thoracic surgeon, pulmonologist and anaesthetist who will need to be in agreement on inoperability and/or lack of cardiopulmonary reserve)

排除标准

  • Active tuberculosis
  • High clinical suspicion of lung carcinoma
  • Known deep venous thrombosis or pulmonary embolism
  • Any social or psychological condition that may impair insight or compliance with the study including follow up
  • Any other condition, which in the opinion of the investigators, places the subject at increased risk for transport and administration of EBRT e.g. severe haemodynamic instability, mechanical ventilation with high FiO2 requirements etc.

研究组 & 干预措施

External Beam Radiotherapy

Experimental

Patients will receive radiotherapy (3.5Gy weekly for 5 fractions to a maximum of 17G) prescribed to a central plane using mega-voltage radiation encompassing all the assessed affected lung tissue

干预措施: External beam radiotherapy (Radiation)

Control

No Intervention

Patients will receive best medical care.

结局指标

主要结局

Composite end-point of time to recurrent life-threatening haemoptysis, or death

时间窗: 1 year

次要结局

  • Radiological change in volume (maximum diameters in three planes)(1 year)
  • Six minute walk test(1 year)
  • Time to massive haemoptysis (>200mL per day)(1 year)
  • Fev1/FVC(1 year)
  • Total lung capacity (TLC) Total lung capacity (TLC)(1 year)
  • Number of complications associated with Radiotherapy(1 year)
  • Diffusion capacity (DLCO) Total lung capacity (TLC)(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Brian Allwood

Principal investigator

University of Stellenbosch

研究点 (2)

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