Martin Geoffrey A, Tsim Selina, Kidd Andrew C, Foster John E, McLoone Philip, Chalmers Anthony, Blyth Kevin G
Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.
Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.
BMJ Open Respir Res. 2018 May 29;5(1):e000293. doi: 10.1136/bmjresp-2018-000293. eCollection 2018.
Non-expansile lung (NEL) is a common cause of talc pleurodesis (TP) failure in malignant pleural effusion (MPE), but is often occult prior to drainage. Reliable detection of NEL would allow patients to be allocated between intrapleural catheter (IPC) and TP. High pleural elastance (P) has been associated with NEL in observational studies. Pre-EDIT is a randomised feasibility trial of elastance-directed IPC or TP (EDIT) management using a novel, purpose-built digital pleural manometer (Rocket Medical, UK).
Consecutive patients with MPE without prior evidence of NEL or preference for IPC will be randomised 1:1 between EDIT management and standard care (an attempt at TP). The primary objective is to determine whether sufficient numbers of patients (defined as 30 within 12 months (or 15 over 6 months)) can be recruited and randomised to justify a subsequent phase III trial testing the efficacy of EDIT management. Secondary objectives include safety, technical feasibility and validation of study design elements, including the definition of P using 4D pleural MRI before and after fluid aspiration. EDIT involves P assessment during a large volume pleural fluid aspiration, followed by an attempt at TP or placement of an IPC within 24 hours. Patients will be allocated to IPC if the rolling average P sustained over at least 250 mL fluid aspirated (P) is ≥ 14.5 cm HO/L.
Pre-EDIT was approved by the West of Scotland Regional Ethics Committee on 8 March 2017 (Ref: 17/WS/0042). Results will be presented at scientific meetings and published in peer-reviewed journals.
NCT03319186; Pre-results.
非扩张性肺（NEL）是恶性胸腔积液（MPE）中滑石粉胸膜固定术（TP）失败的常见原因，但在胸腔引流前通常难以察觉。可靠检测NEL将有助于在胸腔内导管（IPC）和TP之间合理分配患者。在观察性研究中，高胸膜弹性（P）与NEL相关。Pre-EDIT是一项随机可行性试验，采用新型特制数字胸膜压力计（英国Rocket Medical公司）对弹性导向的IPC或TP（EDIT）管理进行研究。
连续入选的无NEL既往证据或无IPC偏好的MPE患者将按1:1随机分配至EDIT管理组和标准治疗组（尝试进行TP）。主要目标是确定是否能招募到足够数量的患者（定义为12个月内30例（或6个月内15例））并进行随机分组，以证明后续III期试验检验EDIT管理疗效的合理性。次要目标包括安全性、技术可行性以及研究设计要素的验证，包括通过液体抽吸前后的4D胸膜MRI定义P。EDIT包括在大量胸腔积液抽吸过程中评估P，然后在24小时内尝试进行TP或放置IPC。如果在至少抽吸250 mL液体期间维持的滚动平均P（P）≥14.5 cm H₂O/L，则将患者分配至IPC组。
Pre-EDIT于2017年3月8日获得苏格兰西部地区伦理委员会批准（参考编号：17/WS/0042）。研究结果将在科学会议上公布，并发表在同行评审期刊上。
NCT03319186；预结果。
