Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK; Institute of Cancer Sciences, University of Glasgow, Glasgow, UK.
Pleural Disease Unit, Queen Elizabeth University Hospital, Glasgow, UK.
Chest. 2019 Dec;156(6):1204-1213. doi: 10.1016/j.chest.2019.07.010. Epub 2019 Jul 30.
Talc slurry pleurodesis (TSP) prevents recurrence of symptomatic malignant pleural effusion (MPE) in 71% to 78% patients. Nonexpansile lung (NEL) frequently accounts for TSP failure but is often occult predrainage, impairing selection of patients. NEL is associated with high pleural elastance (P), but technical limitations have hampered the development of P as a predictive NEL marker. We performed a single-center, randomized, controlled, open-label feasibility trial of EDIT (elastance-directed indwelling pleural catheter or TSP) management, using a novel digital manometer and a new definition of high P.
Patients with symptomatic MPE were randomized 1:1 between EDIT and standard care (TSP). EDIT involved P assessment during large-volume thoracentesis; patients with high P (maximum P sustained over 250 mL [MaxP] ≥ 14.5 cm HO/L) were allocated to immediately receive an indwelling pleural catheter; the remainder underwent immediate drain placement for TSP. The primary outcome measure was recruitment feasibility, defined a priori as 30 patients over 12 months. Secondary outcomes included safety, technical reliability, and the aspiration volume required to detect high P. The accuracy of the P definition for NEL was analyzed post hoc.
Thirty-one patients were randomized (one allocation failure) over 12 months. P assessment (mean duration, 33 minutes) was successful in 13 of 15 patients (87%). No directly attributable serious adverse events occurred. High P was detected in seven of 13 patients (54%), associated with 100% sensitivity and 67% specificity for NEL, and was first detected at a median volume of 325 mL (range, 250-800 mL).
A phase 3 trial testing the effect of EDIT management on symptomatic MPE recurrence following TSP is feasible.
ClinicalTrials.gov; No.: NCT03319186; URL: www.clinicaltrials.gov.
滑石粉浆胸膜固定术（TSP）可使 71%至 78%的有症状恶性胸腔积液（MPE）患者复发。非扩张性肺（NEL）常导致 TSP 失败，但常为引流前隐匿性，影响患者选择。NEL 与高胸膜弹性（P）相关，但技术限制阻碍了 P 作为预测 NEL 标志物的发展。我们进行了一项单中心、随机、对照、开放性 EDIT（弹性导向留置胸膜导管或 TSP）管理的可行性试验，使用了一种新型数字测压计和高 P 的新定义。
有症状 MPE 的患者按 1:1 随机分为 EDIT 和标准治疗（TSP）组。EDIT 包括大容量胸腔穿刺时的 P 评估；高 P（最大 P 持续超过 250 mL [MaxP]≥14.5 cm HO/L）的患者立即分配留置胸膜导管；其余患者立即放置引流管进行 TSP。主要结局指标为预先定义的招募可行性，定义为 12 个月内 30 例患者。次要结局包括安全性、技术可靠性和检测高 P 所需的抽吸量。事后分析了 P 定义对 NEL 的准确性。
12 个月内随机分配了 31 例患者（1 例分配失败）。15 例患者中的 13 例（87%）成功进行了 P 评估（平均持续时间 33 分钟）。无直接归因的严重不良事件发生。13 例患者中的 7 例（54%）检测到高 P，NEL 的敏感性为 100%，特异性为 67%，中位检测体积为 325 mL（范围 250-800 mL）。
检测 EDIT 管理对 TSP 后有症状 MPE 复发影响的 3 期试验是可行的。
ClinicalTrials.gov；编号：NCT03319186；网址：www.clinicaltrials.gov。
