Bhatnagar Rahul, Laskawiec-Szkonter Magda, Piotrowska Hania E G, Kahan Brennan C, Hooper Clare E, Davies Helen E, Harvey John E, Miller Robert F, Rahman Najib M, Maskell Nick A
Respiratory Research Unit, North Bristol NHS Trust, Southmead Hospital, Bristol, UK Academic Respiratory Unit, University of Bristol, Bristol, UK.
Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.
BMJ Open. 2014 Nov 26;4(11):e007045. doi: 10.1136/bmjopen-2014-007045.
The management of recurrent malignant pleural effusions (MPE) can be challenging. Various options are available, with the most efficacious and widely used being talc pleurodesis. Talc can either be applied via a chest drain in the form of slurry, or at medical thoracoscopy using poudrage. Current evidence regarding which method is most effective is conflicting and often methodologically flawed. The TAPPS trial is a suitably powered, multicentre, open-label, randomised controlled trial designed to compare the pleurodesis success rate of medical thoracoscopy and talc poudrage with chest drain insertion and talc slurry.
330 patients with a confirmed MPE requiring intervention will be recruited from UK hospitals. Patients will be randomised (1:1) to undergo either small bore (<14 Fr) Seldinger chest drain insertion followed by instillation of sterile talc (4 g), or to undergo medical thoracoscopy and simultaneous poudrage (4 g). The allocated procedure will be performed as an inpatient within 3 days of randomisation taking place. Following discharge, patients will be followed up at regular intervals for 6 months. The primary outcome measure is pleurodesis failure rates at 3 months. Pleurodesis failure is defined as the need for further pleural intervention for fluid management on the side of the trial intervention.
The trial has received ethical approval from the National Research Ethics Service Committee North West-Preston (12/NW/0467). There is a trial steering committee which includes independent members and a patient and public representative. The trial results will be published in a peer-reviewed journal and presented at international conferences, as well as being disseminated via local and national charities and patient groups. All participants who wish to know the study results will also be contacted directly on their publication.
ISRCTN47845793.
复发性恶性胸腔积液（MPE）的管理具有挑战性。有多种选择，其中最有效且应用最广泛的是滑石粉胸膜固定术。滑石粉既可以通过胸腔引流管以悬液的形式应用，也可以在内科胸腔镜检查时采用撒粉法应用。关于哪种方法最有效，目前的证据相互矛盾，而且在方法学上往往存在缺陷。TAPPS试验是一项样本量充足的多中心、开放标签、随机对照试验，旨在比较内科胸腔镜检查及滑石粉撒粉法与胸腔引流管置入及滑石粉悬液法的胸膜固定成功率。
将从英国医院招募330例确诊需要干预的MPE患者。患者将被随机分组（1:1），分别接受细口径（<14 Fr）Seldinger胸腔引流管置入，随后注入无菌滑石粉（4 g），或接受内科胸腔镜检查并同时撒粉（4 g）。分配的操作将在随机分组后的3天内作为住院治疗进行。出院后将对患者进行定期随访，为期6个月。主要结局指标是3个月时的胸膜固定失败率。胸膜固定失败定义为在试验干预侧需要进一步进行胸膜干预以处理胸腔积液。
该试验已获得西北普雷斯顿国家研究伦理服务委员会的伦理批准（12/NW/0467）。设有试验指导委员会，其中包括独立成员以及患者和公众代表。试验结果将发表在同行评审期刊上，并在国际会议上公布，同时还将通过地方和国家慈善机构以及患者团体进行传播。所有希望了解研究结果的参与者在结果发表时也将直接收到通知。
ISRCTN47845793。
