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首页> 外文OA文献 >The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial.
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The efficacy of indwelling pleural catheter placement versus placement plus talc sclerosant in patients with malignant pleural effusions managed exclusively as outpatients (IPC-PLUS): study protocol for a randomised controlled trial.

机译：恶性胸腔积液患者的留置胸腔导管置入与放置加滑石硬化剂的疗效（IPC-PLUS）：一项随机对照试验的研究方案。

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BACKGROUND: Malignant pleural effusions (MPEs) remain a common problem, with 40,000 new cases in the United Kingdom each year and up to 250,000 in the United States. Traditional management of MPE usually involves an inpatient stay with placement of a chest drain, followed by the instillation of a pleural sclerosing agent such as talc, which aims to minimise further fluid build-up. Despite a good success rate in studies, this approach can be expensive, time-consuming and inconvenient for patients. More recently, an alternative method has become available in the form of indwelling pleural catheters (IPCs), which can be inserted and managed in an outpatient setting. It is currently unknown whether combining talc pleurodesis with IPCs will provide improved pleural symphysis rates over those of IPCs alone. METHODS/DESIGN: IPC-PLUS is a patient-blind, multicentre randomised controlled trial (RCT) comparing the combination of talc with an IPC to the use of an IPC alone for inducing pleurodesis in MPEs. The primary outcome is successful pleurodesis at five weeks post-randomisation. This study will recruit 154 patients, with an interim analysis for efficacy after 100 patients, and aims to help to define the future gold standard for outpatient management of patients with symptomatic MPEs. DISCUSSION: IPC-PLUS is the first RCT to examine the practicality and utility of talc administered via an IPC. The study remains in active recruitment and has the potential to significantly alter how patients requiring pleurodesis for MPE are approached in the future. TRIAL REGISTRATION: This trial was registered with Current Controlled Trials (identifier: ISRCTN73255764 ) on 23 August 2012.
机译：背景：恶性胸腔积液（MPE）仍然是一个普遍的问题，在英国每年有40,000例新病例，在美国则高达25万例。 MPE的传统治疗方法通常是在住院期间放置胸腔引流管，然后滴入诸如滑石粉之类的胸膜硬化剂，以最大程度地减少积液。尽管研究成功率很高，但是这种方法对于患者而言可能是昂贵，费时且不便的。最近，一种替代方法以留置胸膜导管（IPC）的形式出现，可以在门诊病人环境中插入和管理。目前尚不清楚滑石胸膜固定术与IPC结合是否会比单纯IPC提供更高的胸膜联合率。方法/设计：IPC-PLUS是一项患者盲，多中心随机对照试验（RCT），将滑石粉与IPC的组合与单独使用IPC诱导MPE的胸膜固定术进行了比较。主要结果是随机化后五周成功完成胸膜固定术。这项研究将招募154位患者，并对100位患者后的疗效进行中期分析，旨在帮助定义未来有症状MPE患者门诊治疗的金标准。讨论：IPC-PLUS是第一个研究通过IPC施用滑石粉的实用性和实用性的RCT。该研究仍在积极招募中，并有可能显着改变将来需要MPE胸膜固定术的患者的方式。试验注册：该试验已于2012年8月23日在“当前对照试验”中注册（标识符：ISRCTN73255764）。

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