Evaluating the efficacy of Thoracoscopy And talc Poudrage versus Pleurodesis using talc Slurry: A randomised, open-label trial to determine the most effective method for the management of malignant pleural effusions in patients with a good performance status

orth Bristol NHS Trust (UK)0 个研究点目标入组 330 人开始时间: 2012年5月28日最近更新: 2020年1月6日

适应症

试验速览

•1. Clinically confident diagnosis of malignant pleural effusion requiring pleurodesis, defined as:
•1.1. Pleural effusion with histocytologically proven pleural malignancy OR
•1.2. Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
•1.3. Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
•2. Fit enough to undergo local anaesthetic thoracoscopy, as per British Thoracic Society (BTS) guidelines
•3. Expected survival >3 months
•4. Written, informed consent to trial participation

•1. Patients in whom thoracoscopy is the only reasonable approach to making a diagnosis, and in whom such a diagnosis would significantly influence further management
•2. Age < 18 years
•3. Females who are pregnant or lactating
•4. Evidence of extensive lung entrapment on chest X-ray (CXR) or CT, or significant fluid loculation on ultrasound scan, to a level which would normally be a contraindication to attempted talc pleurodesis
•5. Insufficient volume or position of pleural fluid on lateral decubitus thoracic ultrasound to safely perform local anaesthetic thoracoscopy without further intervention being necessary
•6. Previously documented adverse reaction to talc
•7. Clear contraindication to thoracoscopy or chest tube insertion

发起方

orth Bristol NHS Trust (UK)