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首页> 外文期刊>BMJ Open >Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry (TAPPS trial): protocol of an open-label randomised controlled trial
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Evaluating the efficacy of thoracoscopy and talc poudrage versus pleurodesis using talc slurry (TAPPS trial): protocol of an open-label randomised controlled trial

机译：使用滑石粉评估胸腔镜和滑石粉对胸膜固定术的疗效（TAPPS试验）：一项开放标签的随机对照试验方案

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Introduction 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. Methods and analysis 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. Ethics and dissemination 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. Trial registration number ISRCTN47845793.
机译：简介复发性恶性胸腔积液（MPE）的管理可能具有挑战性。有多种选择，其中最有效和最广泛使用的是滑石胸膜固定术。滑石粉可以通过浆液形式的胸腔引流管使用，也可以在医用胸腔镜检查中使用软膏来使用。关于哪种方法最有效的最新证据相互矛盾，并且在方法上常常存在缺陷。 TAPPS试验是一项具有适当动力，多中心，开放标签，随机对照的试验，旨在比较医用胸腔镜检查和滑石粉与胸腔引流和滑石浆的胸膜固定术成功率。方法和分析将从英国医院招募330名确诊为MPE且需要干预的患者。患者将被随机分配（1：1）进行小口径（<14？Fr）Seldinger胸腔引流术，然后滴注无菌滑石粉（4？g），或接受医疗胸腔镜检查和同时补足（4？g）。分配的程序将在发生随机化的3天之内作为住院病人执行。出院后，将定期随访患者6个月。主要结局指标是3个月大的胸膜固定术失败率。胸膜固定术失败的定义是在试验干预方面需要进一步的胸膜干预以进行液体管理。伦理和传播该试验已获得美国西北国家研究伦理服务委员会普雷斯顿（12 / NW / 0467）的伦理批准。有一个试验指导委员会，由独立成员以及患者和公共代表组成。该试验结果将发表在同行评审的期刊上，并在国际会议上发表，并通过地方和国家的慈善机构和患者团体进行传播。所有希望了解研究结果的参与者也将在其出版物上直接联系。试用注册号ISRCTN47845793。

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