From the Departments of Radiology (M.M., N.M., K.T.B., C.L.Z., M.J., C.I.G., C.T.S., J.P.E., A.M.C., L.A.B., H.Y., A.R.D., Y.B., W.A., R.H.S., J.C.D., A.J.G., E.Z., F.E.B., S.B.S.) and Epidemiology and Biostatistics (C.S.M., M.H.), Memorial Sloan Kettering Cancer Center, 1275 York Ave, M276C, New York, NY 10065.
Radiology. 2019 Feb;290(2):547-554. doi: 10.1148/radiol.2018181140. Epub 2018 Nov 27.
Purpose To compare the effect of autologous blood patch injection (ABPI) with that of a hydrogel plug on the rate of pneumothorax at CT-guided percutaneous lung biopsy. Materials and Methods In this prospective randomized controlled trial ( https://ClinicalTrials.gov , NCT02224924), a noninferiority design was used for ABPI, with a 10% noninferiority margin when compared with the hydrogel plug, with the primary outcome of pneumothorax rate within 2 hours of biopsy. A type I error rate of 0.05 and 90% power were specified with a target study population of 552 participants (276 in each arm). From October 2014 to February 2017, all potential study participants referred for CT-guided lung biopsy (n = 2052) were assessed for enrollment. Results The data safety monitoring board recommended the trial be closed to accrual after an interim analysis met prespecified criteria for early stopping based on noninferiority. The final study group consisted of 453 participants who were randomly assigned to the ABPI (n = 226) or hydrogel plug (n = 227) arms. Of these, 407 underwent lung biopsy. Pneumothorax rates within 2 hours of biopsy were 21% (42 of 199) and 29% (60 of 208); chest tube rates were 9% (18 of 199) and 13% (27 of 208); and delayed pneumothorax rates within 2 weeks after biopsy were 1.4% (three of 199) and 1.5% (three of 208) in the ABPI and hydrogel plug arms, respectively. Conclusion Autologous blood patch injection is noninferior to a hydrogel plug regarding the rate of pneumothorax after CT-guided percutaneous lung biopsy. © RSNA, 2018 Online supplemental material is available for this article.
目的 比较自体血贴注射（ABPI）与水凝胶塞对 CT 引导经皮肺活检气胸发生率的影响。
材料与方法 这是一项前瞻性随机对照试验（https://ClinicalTrials.gov ，NCT02224924），采用非劣效性设计比较 ABPI，与水凝胶塞相比，非劣效性边界为 10%，主要结局为活检后 2 小时内气胸发生率。指定Ⅰ型错误率为 0.05，效能为 90%，目标研究人群为 552 例参与者（每组 276 例）。2014 年 10 月至 2017 年 2 月，对所有接受 CT 引导肺活检的潜在研究参与者（n=2052）进行了入组评估。
结果 数据安全监测委员会根据中期分析符合提前终止的预设标准，建议试验在达到目标入组人数后停止入组。最终研究组由 453 例参与者组成，随机分为 ABPI（n=226）或水凝胶塞（n=227）组。其中，407 例进行了肺活检。活检后 2 小时内气胸发生率分别为 21%（42/199）和 29%（60/208）；胸腔引流管发生率分别为 9%（18/199）和 13%（27/208）；活检后 2 周内迟发性气胸发生率分别为 1.4%（3/199）和 1.5%（3/208）。
结论 与水凝胶塞相比，ABPI 对 CT 引导经皮肺活检后气胸发生率无差异。
©RSNA，2018
在线补充材料可在本文中获取。
