Division of Thoracic Surgery and Interventional Pulmonology, Swedish Cancer Institute, Seattle, Washington.
JAMA Netw Open. 2023 Apr 3;6(4):e237799. doi: 10.1001/jamanetworkopen.2023.7799.
There is a paucity of high-quality prospective randomized clinical trials comparing intrapleural fibrinolytic therapy (IPFT) with surgical decortication in patients with complicated pleural infections.
To assess the feasibility, safety, and efficacy of an algorithm comparing tissue plasminogen activator plus deoxyribonuclease therapy with surgical decortication in patients with complicated pleural infections.
DESIGN, SETTING, AND PARTICIPANTS: This parallel pilot randomized clinical trial was performed at a single urban community-based center from March 1, 2019, to December 31, 2021, with follow-up for 90 days. Seventy-four individuals were screened and 48 were excluded. Twenty-six patients 18 years or older with clinical pleural infection and positive findings of pleural fluid analysis were included. Of these, 20 patients underwent randomized selection (10 in each group), and 6 were observed.
Intrapleural tissue plasminogen activator plus deoxyribonuclease therapy vs surgical decortication.
Primary outcomes were the percentage of patients enrolled to study completion and multidisciplinary adherence. Secondary outcomes included the number of patients with and the reason for inadequate screening, screening to enrollment failures, time to accrual of 20 patients or the number accrued at 1 year, and clinical data.
Twenty-six patients were enrolled, 10 were randomized to each group, and 6 were observed. There was 100% enrollment to study completion in each treatment group, no protocol deviations, 2 minor protocol amendments, and no screening to enrollment failures. It took 32 months to enroll 26 patients. The 20 randomized patients had a median age of 57 (IQR, 46-65) years, were predominantly men (15 [75%]), and had a median RAPID (Renal, Age, Purulence, Infection Source, and Dietary Factors) score of 2 (IQR, 1-3). Treatment failure occurred in 1 patient and 2 crossover treatments occurred, all of which were in the IPFT group. Intraprocedure and postprocedure complications were similar between the groups. There were no reoperations or in-hospital deaths. Median duration of chest tube use was comparable in the IPFT (5 [IQR, 4-8] days) and surgery (4 [IQR, 3-5] days) groups (P = .21). Median hospital stay tended to be longer in the IPFT (11 [IQR, 4-18] days) vs surgery (5 [IQR, 4-6] days) groups, although the difference as not significantly different (P = .08). There were no 30-day readmissions or 30- or 90-day deaths.
In this pilot randomized clinical trial, the study algorithm was feasible, safe, and efficacious. This provides evidence to move forward with a multicenter randomized clinical trial.
ClinicalTrials.gov Identifier: NCT03873766.
在复杂的胸膜感染患者中，比较胸膜内纤维蛋白溶解疗法（IPFT）与外科剥除术的高质量前瞻性随机临床试验很少。
评估组织纤溶酶原激活剂加脱氧核糖核酸酶治疗与外科剥除术比较的算法在复杂胸膜感染患者中的可行性、安全性和疗效。
设计、地点和参与者：这是一项单中心、平行的试点随机临床试验，于 2019 年 3 月 1 日至 2021 年 12 月 31 日在一个城市社区中心进行，随访 90 天。共筛选了 74 人，排除了 48 人。纳入了 26 名年龄在 18 岁或以上、有临床胸膜感染和胸膜液分析阳性发现的患者。其中，20 名患者接受了随机选择（每组 10 名），6 名患者接受了观察。
胸膜内组织纤溶酶原激活剂加脱氧核糖核酸酶治疗与外科剥除术。
主要结果是纳入研究完成和多学科依从性的患者百分比。次要结果包括患者数量和不充分筛选的原因、筛选到纳入失败、招募 20 名患者或 1 年内招募的患者数量以及临床数据。
共纳入 26 名患者，每组 10 名随机分组，6 名观察。每个治疗组的入组率均为 100%，无方案偏离，有 2 项方案修正案，无筛选到纳入失败。招募 26 名患者耗时 32 个月。20 名随机患者的中位年龄为 57 岁（IQR，46-65 岁），主要为男性（15 名[75%]），中位 RAPID（肾脏、年龄、脓液、感染源和饮食因素）评分为 2（IQR，1-3）。1 名患者治疗失败，2 名患者发生交叉治疗，均发生在 IPFT 组。两组间术中及术后并发症相似。无再次手术或院内死亡。IPFT 组（5[IQR，4-8]天）和手术组（4[IQR，3-5]天）的中位胸腔引流管使用时间相似（P = .21）。IPFT 组（11[IQR，4-18]天）的中位住院时间较手术组（5[IQR，4-6]天）有延长趋势，但差异无统计学意义（P = .08）。无 30 天内再入院或 30 天或 90 天内死亡。
在这项试点随机临床试验中，研究算法是可行、安全和有效的。这为开展多中心随机临床试验提供了证据。
ClinicalTrials.gov 标识符：NCT03873766。
