多中心随机对照研究：超声造影与超声引导下经皮肝穿刺活检对肝脏局灶性病变的诊断价值比较。
A Multicenter Randomized Controlled Study of Contrast-enhanced US versus US-guided Biopsy of Focal Liver Lesions.
机构信息
From the Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Ultrasonography, Peking University Cancer Hospital and Institute, Beijing 100142, People's Republic of China (W.W., Z.Y.Z., K.Y.); Department of Ultrasonography, Tianjin Third Central Hospital, Tianjin, People's Republic of China (X.J.); Department of Ultrasonography, Shanxi Province Cancer Hospital/ Shanxi Hospital Affiliated to Cancer Hospital, Chinese Academy of Medical Sciences/Cancer Hospital Affiliated to Shanxi Medical University, Taiyuan, People's Republic of China (G.Q.X.); Department of Hepatobiliary Cancer, Liver Cancer Center, Tianjin Medical University Cancer Institute and Hospital, National Clinical Research Center for Cancer, Key Laboratory of Cancer Prevention and Therapy, Tianjin, People's Republic of China (X.L.Z.); Department of Ultrasonography, Yantai Qishan Hospital, Yantai, People's Republic of China (J.W.); Department of Ultrasonography, Shijiazhuang Fifth Hospital, Shijiazhuang, People's Republic of China (R.Q.D.); Department of Ultrasonography, Jining No. 1 People's Hospital, Jining, People's Republic of China (B.L.); Department of Ultrasonography, Cangzhou Infectious Disease Hospital, Cangzhou, People's Republic of China (K.F.W.); Department of Ultrasonography, Shanxi Provincial People's Hospital, Taiyuan, People's Republic of China (J.P.Y.); Department of Epidemiology and Health Statistics, West China School of Public Health and West China Fourth Hospital, Sichuan University, Chengdu, People's Republic of China (M.D.L.); and Division of Gastroenterology and Hepatology, University of California San Diego, San Diego, Calif (Y.K.).
出版信息
Radiology. 2022 Dec;305(3):721-728. doi: 10.1148/radiol.212317. Epub 2022 Aug 2.
Background Retrospective or single-center prospective studies with relatively small samples have shown that contrast-enhanced US (CEUS) can improve the diagnostic accuracy of percutaneous biopsy, but larger prospective studies are lacking. Purpose To assess the diagnostic performance of CEUS-guided biopsy (CEUS-GB) of focal liver lesions (FLLs) compared with US-guided biopsy (US-GB) in a prospective multicenter study. Materials and Methods In this randomized controlled study conducted in nine hospitals in China between March 2016 and August 2019, adult participants with FLLs detected with US, CT, or MRI and planned for percutaneous biopsy were randomly assigned to undergo either US-GB or CEUS-GB. Lesions diagnosed as malignant at histopathologic analysis were considered true-positive findings. Benign or indeterminate lesions required further confirmation with either repeat biopsy or clinical follow-up at 6 months or later. The primary endpoint was the diagnostic accuracy rate, and comparison between groups was made using the χ test. Results In this study, 2056 participants (1297 men, 759 women; mean age, 58 years ± 11 [SD]) were analyzed: 1030 underwent biopsy with US guidance and 1026 underwent biopsy with CEUS guidance. The overall diagnostic accuracy rate of CEUS-GB was 96% (983 of 1026) versus 93% (953 of 1030) for US-GB ( = .002), CEUS-GB enabled correct identification in 96% of participants (983 of 1026) compared with 92% (953 of 1030) with US-GB ( = .002). The negative predictive value (NPV) for both biopsy methods was moderate but significantly higher for CEUS-GB than for US-GB (74% vs 57%, = .001). The difference was remarkable for lesions smaller than 2.0 cm, with CEUS-GB showing higher diagnostic accuracy (96% vs 88%, = .004) and sensitivity (95% vs 87%, = .007) than US-GB. Among lesions smaller than 2.0 cm, the accuracy of CEUS-GB and US-GB for detection of hepatocellular carcinoma was 93% and 80%, respectively ( = .008), while it was comparable for liver metastases (98% vs 95%, = .63). Conclusion Contrast-enhanced US-guided biopsy of focal liver lesions is an effective and safe procedure with a higher diagnostic accuracy than US-guided biopsy, especially for lesions smaller than 2.0 cm and for hepatocellular carcinoma diagnosis. Clinical trial registration no. NCT02413437 © RSNA, 2022
背景 回顾性或单中心前瞻性研究显示，对比增强超声（CEUS）可提高经皮活检的诊断准确性，但缺乏更大规模的前瞻性研究。目的 在一项多中心前瞻性研究中，评估 CEUS 引导下肝局灶性病变（FLL）活检（CEUS-GB）与 US 引导下活检（US-GB）的诊断性能。材料与方法 本研究为 2016 年 3 月至 2019 年 8 月在中国 9 家医院进行的一项随机对照研究，纳入 US、CT 或 MRI 检测到 FLL 并计划行经皮活检的成年参与者，按 1∶1 随机分配至 US-GB 或 CEUS-GB 组。组织病理学分析诊断为恶性的病灶被认为是真阳性发现。良性或不确定的病灶需要通过重复活检或临床随访（6 个月或更长时间）进一步确认。主要终点是诊断准确率，组间比较采用 χ 检验。结果 本研究共纳入 2056 名参与者（男 1297 名，女 759 名；平均年龄，58 岁±11[标准差]）：1030 名接受 US 引导活检，1026 名接受 CEUS 引导活检。CEUS-GB 的总体诊断准确率为 96%（1026 例中的 983 例），US-GB 为 93%（1030 例中的 953 例）（ =.002），CEUS-GB 能正确识别 96%（1026 例中的 983 例）的参与者，而 US-GB 为 92%（1030 例中的 953 例）（ =.002）。两种活检方法的阴性预测值（NPV）均为中等，但 CEUS-GB 的 NPV 显著高于 US-GB（74%比 57%， =.001）。对于直径小于 2.0 cm 的病灶，CEUS-GB 的诊断准确率（96%比 88%， =.004）和敏感度（95%比 87%， =.007）均高于 US-GB，差异显著。在直径小于 2.0 cm 的病灶中，CEUS-GB 和 US-GB 检测肝细胞癌的准确率分别为 93%和 80%（ =.008），但检测肝转移癌的准确率相当（98%比 95%， =.63）。结论 CEUS 引导下肝局灶性病变活检是一种有效且安全的方法，其诊断准确性优于 US 引导下活检，尤其对于直径小于 2.0 cm 的病灶和肝细胞癌的诊断。临床试验注册编号 NCT02413437 © RSNA，2022
Zotero 插件