Role of thoracic ultrasonography in pleurodesis pathways for malignant pleural effusions (SIMPLE): an open-label, randomised controlled trial,The Lancet Respiratory Medicine

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Role of thoracic ultrasonography in pleurodesis pathways for malignant pleural effusions (SIMPLE): an open-label, randomised controlled trial
The Lancet Respiratory Medicine ( IF 38.7 ) Pub Date : 2021-10-08 , DOI: 10.1016/s2213-2600(21)00353-2
Ioannis Psallidas ₁ , Maged Hassan ₂ , Ahmed Yousuf ₁ , Tracy Duncan ₃ , Shahul Leyakathali Khan ₄ , Kevin G Blyth ₅ , Matthew Evison ₆ , John P Corcoran ₇ , Simon Barnes ₈ , Raja Reddy ₉ , Peter I Bonta ₁₀ , Rahul Bhatnagar ₁₁ , Gayathri Kagithala ₁₂ , Melissa Dobson ₁₂ , Ruth Knight ₁₃ , Susan J Dutton ₁₃ , Ramon Luengo-Fernandez ₁₄ , Emma Hedley ₁₂ , Hania Piotrowska ₁₂ , Louise Brown ₃ , Kamal Abi Musa Asa'ari ₄ , Rachel M Mercer ₁ , Rachelle Asciak ₁ , Eihab O Bedawi ₁ , Rob J Hallifax ₁ , Mark Slade ₁₅ , Rachel Benamore ₁₆ , Anthony Edey ₁₇ , Robert F Miller ₁₈ , Nick A Maskell ₁₁ , Najib M Rahman ₁₉

Affiliation

Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.
Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Chest Diseases Department, Alexandria University Faculty of Medicine, Alexandria, Egypt.
Department of Respiratory Medicine, North Manchester General Hospital, Manchester, UK.
Department of Respiratory Medicine, University Hospitals of North Midlands NHS Trust, Stoke-on-Trent, UK.
Institute of Cancer Sciences, University of Glasgow and Glasgow Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.
North West Lung Centre, University Hospital of South Manchester NHS Foundation Trust, Manchester, UK.
Interventional Pulmonology Unit, Chest Clinic, University Hospitals Plymouth NHS Trust, Plymouth, UK.
Department of Respiratory Medicine, Somerset NHS Foundation Trust, Taunton, UK.
Department of Respiratory Medicine, Kettering General Hospital, Kettering, UK.
Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, Netherlands.
Academic Respiratory Unit, University of Bristol, Bristol, UK.
Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK.
Oxford Clinical Trials Research Unit, Centre for Statistics in Medicine, University of Oxford, Oxford, UK.
Health Economics Research Centre, Nuffield Department of Population Health, University of Oxford, Oxford, UK.
Department of Respiratory Medicine, Gloucestershire Hospitals NHS Foundation Trust, Gloucester, UK.
Department of Thoracic Imaging, Oxford University Hospitals NHS Foundation Trust, Oxford, UK.
Department of Imaging, North Bristol NHS Trust, Bristol, UK.
Institute for Global Health, University College London, London, UK.
Oxford Centre for Respiratory Medicine, Oxford University Hospitals NHS Foundation Trust, Oxford, UK; Oxford Respiratory Trials Unit, University of Oxford, Oxford, UK; Oxford NIHR Biomedical Research Centre, Oxford, UK.

Background

Pleurodesis is done as an in-patient procedure to control symptomatic recurrent malignant pleural effusion (MPE) and has a success rate of 75–80%. Thoracic ultrasonography has been shown in a small study to predict pleurodesis success early by demonstrating cessation of lung sliding (a normal sign seen in healthy patients, lung sliding indicates normal movement of the lung inside the thorax). We aimed to investigate whether the use of thoracic ultrasonography in pleurodesis pathways could shorten hospital stay in patients with MPE undergoing pleurodesis.

Methods

The Efficacy of Sonographic and Biological Pleurodesis Indicators of Malignant Pleural Effusion (SIMPLE) trial was an open-label, randomised controlled trial done in ten respiratory centres in the UK and one respiratory centre in the Netherlands. Adult patients (aged ≥18 years) with confirmed MPE who required talc pleurodesis via either a chest tube or as poudrage during medical thorascopy were eligible. Patients were randomly assigned (1:1) to thoracic ultrasonography-guided care or standard care via an online platform using a minimisation algorithm. In the intervention group, daily thoracic ultrasonography examination for lung sliding in nine regions was done to derive an adherence score: present (1 point), questionable (2 points), or absent (3 points), with a lowest possible score of 9 (preserved sliding) and a highest possible score of 27 (complete absence of sliding); the chest tube was removed if the score was more than 20. In the standard care group, tube removal was based on daily output volume (per British Thoracic Society Guidelines). The primary outcome was length of hospital stay, and secondary outcomes were pleurodesis failure at 3 months, time to tube removal, all-cause mortality, symptoms and quality-of-life scores, and cost-effectiveness of thoracic ultrasonography-guided care. All outcomes were assessed in the modified intention-to-treat population (patients with missing data excluded), and a non-inferiority analysis of pleurodesis failure was done in the per-protocol population. This trial was registered with ISRCTN, ISRCTN16441661.

Findings

Between Dec 31, 2015, and Dec 17, 2019, 778 patients were assessed for eligibility and 313 participants (165 [53%] male) were recruited and randomly assigned to thoracic ultrasonography-guided care (n=159) or standard care (n=154). In the modified intention-to-treat population, the median length of hospital stay was significantly shorter in the intervention group (2 days [IQR 2–4]) than in the standard care group (3 days [2–5]; difference 1 day [95% CI 1–1]; p<0·0001). In the per-protocol analysis, thoracic ultrasonography-guided care was non-inferior to standard care in terms of pleurodesis failure at 3 months, which occurred in 27 (29·7%) of 91 patients in the intervention group versus 34 (31·2%) of 109 patients in the standard care group (risk difference −1·5% [95% CI −10·2% to 7·2%]; non-inferiority margin 15%). Mean time to chest tube removal in the intervention group was 2·4 days (SD 2·5) versus 3·1 days (2·0) in the standard care group (mean difference −0·72 days [95% CI −1·22 to −0·21]; p=0·0057). There were no significant between-group differences in all-cause mortality, symptom scores, or quality-of-life scores, except on the EQ-5D visual analogue scale, which was significantly lower in the standard care group at 3 months. Although costs were similar between the groups, thoracic ultrasonography-guided care was cost-effective compared with standard care.

Interpretation

Thoracic ultrasonography-guided care for pleurodesis in patients with MPE results in shorter hospital stay (compared with the British Thoracic Society recommendation for pleurodesis) without reducing the success rate of the procedure at 3 months. The data support consideration of standard use of thoracic ultrasonography in patients undergoing MPE-related pleurodesis.

Funding

Marie Curie Cancer Care Committee

中文翻译：

胸部超声在恶性胸腔积液胸膜固定术中的作用 (SIMPLE)：一项开放标签、随机对照试验

背景

胸膜固定术作为一种住院手术来控制有症状的复发性恶性胸腔积液 (MPE)，成功率为 75-80%。一项小型研究表明，胸部超声检查可通过显示肺部滑动停止（在健康患者中看到的正常体征，肺部滑动表明肺部在胸腔内的正常运动）来早期预测胸膜固定术的成功。我们旨在调查在胸膜固定术中使用胸部超声检查是否可以缩短接受胸膜固定术的 MPE 患者的住院时间。

方法

恶性胸腔积液超声和生物胸膜固定术指标的疗效 (SIMPLE) 试验是一项开放标签、随机对照试验，在英国的 10 个呼吸中心和荷兰的一个呼吸中心进行。确诊 MPE 的成年患者（年龄≥18 岁）需要通过胸管或在医学胸腔镜检查期间作为粉剂进行滑石粉胸膜固定术是合格的。通过使用最小化算法的在线平台，患者被随机分配 (1:1) 接受胸部超声引导护理或标准护理。在干预组中，每天对 9 个区域的肺滑动进行胸部超声检查以得出依从性评分：存在（1 分）、有问题（2 分）或不存在（3 分），最低分 9 分（保持滑动）和最高分 27 分（完全没有滑动）；如果分数超过 20，则拔除胸管。在标准护理组中，导管拔除基于每日输出量（根据英国胸科学会指南）。主要结果是住院时间，次要结果是 3 个月时胸膜固定术失败、拔管时间、全因死亡率、症状和生活质量评分，以及胸部超声引导治疗的成本效益。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。如果分数超过 20，则拔除胸管。在标准护理组中，导管拔除基于每日输出量（根据英国胸科学会指南）。主要结果是住院时间，次要结果是 3 个月时胸膜固定术失败、拔管时间、全因死亡率、症状和生活质量评分，以及胸部超声引导治疗的成本效益。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。如果分数超过 20，则拔除胸管。在标准护理组中，导管拔除基于每日输出量（根据英国胸科学会指南）。主要结果是住院时间，次要结果是 3 个月时胸膜固定术失败、拔管时间、全因死亡率、症状和生活质量评分，以及胸部超声引导治疗的成本效益。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。主要结果是住院时间，次要结果是 3 个月时胸膜固定术失败、拔管时间、全因死亡率、症状和生活质量评分，以及胸部超声引导治疗的成本效益。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。主要结果是住院时间，次要结果是 3 个月时胸膜固定术失败、拔管时间、全因死亡率、症状和生活质量评分，以及胸部超声引导治疗的成本效益。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。所有结局均在改良意向治疗人群（排除缺失数据的患者）中进行评估，并在符合方案人群中进行了胸膜固定术失败的非劣效性分析。该试验已在 ISRCTN 注册，ISRCTN16441661。

发现

在 2015 年 12 月 31 日至 2019 年 12 月 17 日期间，对 778 名患者进行了资格评估，招募了 313 名参与者（165 名 [53%] 男性）并随机分配到胸部超声引导护理（n=159）或标准护理（n =154)。在改良意向治疗人群中，干预组的中位住院时间（2 天 [IQR 2-4]）显着短于标准护理组（3 天 [2-5]；差异 1天 [95% CI 1-1]；p<0·0001)。在符合方案分析中，在 3 个月的胸膜固定失败方面，胸部超声引导治疗不劣于标准治疗，干预组 91 名患者中有 27 名 (29·7%) 与 34 名 (31· 2%）标准治疗组 109 名患者（风险差异 -1·5% [95% CI -10·2% 至 7·2%]；非劣效性界值 15%）。干预组拔除胸管的平均时间为 2·4 天 (SD 2·5)，而标准护理组为 3·1 天 (2·0)（平均差 -0·72 天 [95% CI -1 ·22 至 -0·21]；p=0·0057)。除 EQ-5D 视觉模拟量表外，标准治疗组在 3 个月时显着降低了全因死亡率、症状评分或生活质量评分的组间差异。尽管各组之间的成本相似，但与标准护理相比，胸部超声引导的护理具有成本效益。除了 EQ-5D 视觉模拟量表，标准护理组在 3 个月时显着降低。尽管各组之间的成本相似，但与标准护理相比，胸部超声引导的护理具有成本效益。除了 EQ-5D 视觉模拟量表，标准护理组在 3 个月时显着降低。尽管各组之间的成本相似，但与标准护理相比，胸部超声引导的护理具有成本效益。