Respiratory Medicine, Sir Charles Gairdner Hospital, Nedlands, WA, Australia.
Medical School, Faculty of Health & Medical Sciences, University of Western Australia, Perth, WA, Australia.
Trials. 2022 Jun 27;23(1):530. doi: 10.1186/s13063-022-06405-7.
Malignant pleural effusions (MPEs) are common. MPE causes significant breathlessness and impairs quality of life. Indwelling pleural catheters (IPC) allow ambulatory drainage and reduce hospital days and re-intervention rates when compared to standard talc slurry pleurodesis. Daily drainage accelerates pleurodesis, and talc instillation via the IPC has been proven feasible and safe. Surgical pleurodesis via video-assisted thoracoscopic surgery (VATS) is considered a one-off intervention for MPE and is often recommended to patients who are fit for surgery. The AMPLE-3 trial is the first randomised trial to compare IPC (±talc pleurodesis) and VATS pleurodesis in those who are fit for surgery.
A multi-centre, open-labelled randomised trial of patients with symptomatic MPE, expected survival of ≥ 6 months and good performance status randomised 1:1 to either IPC or VATS pleurodesis. Participant randomisation will be minimised for (i) cancer type (mesothelioma vs non-mesothelioma); (ii) previous pleurodesis (vs not); and (iii) trapped lung, if known (vs not). Primary outcome is the need for further ipsilateral pleural interventions over 12 months or until death, if sooner. Secondary outcomes include days in hospital, quality of life (QoL) measures, physical activity levels, safety profile, health economics, adverse events, and survival. The trial will recruit 158 participants who will be followed up for 12 months.
Sir Charles Gairdner and Osborne Park Health Care Group (HREC) has approved the study (reference: RGS356). Results will be published in peer-reviewed journals and presented at scientific meetings.
Both IPC and VATS are commonly used procedures for MPE. The AMPLE-3 trial will provide data to help define the merits and shortcomings of these procedures and inform future clinical care algorithms.
Australia New Zealand Clinical Trial Registry ACTRN12618001013257 . Registered on 18 June 2018.
Version 3.00/4.02.19.
恶性胸腔积液（MPE）很常见。MPE 会导致严重的呼吸困难，降低生活质量。与标准滑石粉胸膜固定术相比，留置胸腔导管（IPC）允许患者活动并减少住院天数和再干预率。每日引流可加速胸膜固定，通过 IPC 进行滑石粉灌洗已被证明是可行且安全的。电视辅助胸腔镜手术（VATS）下的外科胸膜固定术被认为是 MPE 的一次性干预措施，通常推荐给适合手术的患者。AMPLE-3 试验是比较适合手术的患者中 IPC（±滑石粉胸膜固定术）和 VATS 胸膜固定术的首个随机试验。
一项多中心、开放性标签、随机试验，纳入有症状的 MPE、预期生存时间≥6 个月和良好表现状态的患者，以 1:1 的比例随机分配至 IPC 或 VATS 胸膜固定术。参与者的随机分配将针对以下因素进行最小化：（i）癌症类型（间皮瘤与非间皮瘤）；（ii）既往胸膜固定术（与未进行）；和（iii）如果已知（与未知）被困住的肺。主要结局是 12 个月内或更早死亡前需要进行同侧胸膜再次干预。次要结局包括住院天数、生活质量（QoL）测量、身体活动水平、安全性、卫生经济学、不良事件和生存。该试验将招募 158 名参与者，随访 12 个月。
查尔斯·盖尔德纳爵士和奥兹本公园医疗保健集团（HREC）已批准该研究（参考号：RGS356）。结果将发表在同行评议的期刊上，并在科学会议上进行报告。
IPC 和 VATS 都是 MPE 的常用治疗方法。AMPLE-3 试验将提供数据，以帮助确定这些治疗方法的优缺点，并为未来的临床护理算法提供信息。
澳大利亚新西兰临床试验注册 ACTRN12618001013257。于 2018 年 6 月 18 日注册。
第 3.00/4.02.19 版。
