Importance Malignant pleural effusion (MPE) is challenging to manage. Talc pleurodesis is a common and effective treatment. There are no reliable data, however, regarding the optimal method for talc delivery, leading to differences in practice and recommendations. Objective To test the hypothesis that administration of talc poudrage during thoracoscopy with local anesthesia is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis. Design, Setting, and Participants Open-label, randomized clinical trial conducted at 17 UK hospitals. A total of 330 participants were enrolled from August 2012 to April 2018 and followed up until October 2018. Patients were eligible if they were older than 18 years, had a confirmed diagnosis of MPE, and could undergo thoracoscopy with local anesthesia. Patients were excluded if they required a thoracoscopy for diagnostic purposes or had evidence of nonexpandable lung. Interventions Patients randomized to the talc poudrage group (n = 166) received 4 g of talc poudrage during thoracoscopy while under moderate sedation, while patients randomized to the control group (n = 164) underwent bedside chest tube insertion with local anesthesia followed by administration of 4 g of sterile talc slurry. Main Outcomes and Measures The primary outcome was pleurodesis failure up to 90 days after randomization. Secondary outcomes included pleurodesis failure at 30 and 180 days; time to pleurodesis failure; number of nights spent in the hospital over 90 days; patient-reported thoracic pain and dyspnea at 7, 30, 90, and 180 days; health-related quality of life at 30, 90, and 180 days; all-cause mortality; and percentage of opacification on chest radiograph at drain removal and at 30, 90, and 180 days. Results Among 330 patients who were randomized (mean age, 68 years; 181 [55%] women), 320 (97%) were included in the primary outcome analysis. At 90 days, the pleurodesis failure rate was 36 of 161 patients (22%) in the talc poudrage group and 38 of 159 (24%) in the talc slurry group (adjusted odds ratio, 0.91 [95% CI, 0.54-1.55]; P = .74; difference, -1.8% [95% CI, -10.7% to 7.2%]). No statistically significant differences were noted in any of the 24 prespecified secondary outcomes. Conclusions and Relevance Among patients with malignant pleural effusion, thoracoscopic talc poudrage, compared with talc slurry delivered via chest tube, resulted in no significant difference in the rate of pleurodesis failure at 90 days. However, the study may have been underpowered to detect small but potentially important differences. Trial Registration ISRCTN Identifier: ISRCTN47845793.

中文翻译：

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胸腔镜滑石粉与经胸导管滑石浆对恶性胸腔积液患者胸膜固定术失败率的影响

重要性 恶性胸腔积液 (MPE) 难以管理。滑石粉胸膜固定术是一种常见且有效的治疗方法。然而，没有关于滑石粉输送最佳方法的可靠数据，导致实践和建议存在差异。目的 验证在胸腔镜局麻下给予滑石粉浆比通过胸管输送滑石粉浆成功诱导胸膜固定术更有效的假设。设计、设置和参与者 在英国 17 家医院进行的开放标签、随机临床试验。2012 年 8 月至 2018 年 4 月共招募了 330 名参与者，并随访至 2018 年 10 月。 年龄大于 18 岁、确诊为 MPE 且可在局部麻醉下进行胸腔镜检查的患者符合条件。如果患者出于诊断目的需要进行胸腔镜检查或有肺不可扩张的证据，则将其排除在外。干预措施 随机分配到滑石粉组的患者（n = 166）在胸腔镜检查期间在中等镇静状态下接受 4 g 滑石粉，而随机分配到对照组的患者（n = 164）在局部麻醉下进行床边胸管插入，然后给予4 克无菌滑石浆。主要结果和测量 主要结果是随机化后长达 90 天的胸膜固定术失败。次要结局包括 30 天和 180 天胸膜固定术失败；胸膜固定术失败的时间；超过 90 天在医院度过的夜数；患者报告的第 7、30、90 和 180 天的胸痛和呼吸困难；30、90 和 180 天的健康相关生活质量；全因死亡率；以及在去除引流管时和 30、90 和 180 天时胸片上的混浊百分比。结果 在随机分组的 330 名患者（平均年龄 68 岁；181 名 [55%] 女性）中，320 名 (97%) 被纳入主要结局分析。在 90 天时，滑石粉膏组 161 名患者中的 36 名 (22%) 和滑石粉浆组 159 名患者中的 38 名 (24%) 胸膜固定术失败率为 0.91 [95% CI, 0.54-1.55] ；P = .74；差异，-1.8% [95% CI，-10.7% 至 7.2%]）。在 24 个预先指定的次要结果中，没有发现任何具有统计学意义的差异。结论和相关性 在恶性胸腔积液患者中，胸腔镜滑石粉浆与通过胸管输送的滑石粉浆相比，在 90 天胸膜固定术失败率方面没有显着差异。然而，该研究可能不足以检测微小但可能重要的差异。试用注册 ISRCTN 标识符：ISRCTN47845793。