Okanoue Takeshi, Yamaguchi Kanji, Shima Toshihide, Mitsumoto Yasuhide, Katayama Takayuki, Okuda Keiichiro, Mizuno Masayuki, Seko Yuya, Moriguchi Michihisa, Itoh Yoshito, Miyazaki Toru
Department of Gastroenterology and Hepatology, Saiseikai Suita Hospital, Osaka, Japan.
Molecular Gastroenterology and Hepatology, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Hepatol Res. 2023 Dec;53(12):1213-1223. doi: 10.1111/hepr.13955. Epub 2023 Sep 7.
The aim of this study was to develop a novel noninvasive test using an artificial intelligence/neural network system (called HCC-Scope) to diagnose early-stage hepatocellular carcinoma (HCC) on the background of nonalcoholic steatohepatitis (NASH).
In total, 175 patients with histologically proven nonalcoholic fatty liver disease and 55 patients with NASH-HCC were enrolled for training and validation studies. Of the 55 patients with NASH-HCC, 27 (49.1%) had very early-stage HCC, and six (10.9%) had early-stage HCC based on the Barcelona Clinic Liver Cancer staging system. Diagnosis with HCC-Scope was performed based on 12 items: age, sex, height, weight, AST level, ALT level, gamma-glutamyl transferase level, cholesterol level, triglyceride level, platelet count, diabetes status, and IgM-free apoptosis inhibitor of macrophage level. The FMVWG2U47 hardware (Fujitsu Co. Ltd, Tokyo, Japan) and the originally developed software were used.
HCC-Scope had sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of 100% for the differential diagnosis between non-HCC and HCC in a training study with gray zone analysis. It was also excellent in the validation study (95.0% sensitivity, 100% specificity, 100% PPV, and 97.1% NPV with gray zone analysis and 95.2% sensitivity, 100% specificity, 100% PPV, and 97.1% NPV without gray zone analysis). HCC-Scope had a significantly higher sensitivity (85.3%) and specificity (85.1%) than alpha-fetoprotein (AFP) level, AFP-L3 level, des-gamma-carboxy prothrombin (DCP) level, and the gender-age-AFP-L3-AFP-DCP (GALAD) score.
HCC-Scope can accurately differentially diagnose between non-HCC NASH and NASH-HCC, including very early-stage NASH-HCC.
本研究旨在开发一种新型的非侵入性检测方法,利用人工智能/神经网络系统(称为HCC-Scope)在非酒精性脂肪性肝炎(NASH)背景下诊断早期肝细胞癌(HCC)。
总共纳入了175例经组织学证实的非酒精性脂肪性肝病患者和55例NASH-HCC患者进行训练和验证研究。在55例NASH-HCC患者中,根据巴塞罗那临床肝癌分期系统,27例(49.1%)为极早期HCC,6例(10.9%)为早期HCC。基于12项指标进行HCC-Scope诊断:年龄、性别、身高、体重、AST水平、ALT水平、γ-谷氨酰转移酶水平、胆固醇水平、甘油三酯水平、血小板计数、糖尿病状态以及巨噬细胞无IgM凋亡抑制因子水平。使用了FMVWG2U47硬件(日本东京富士通有限公司)和最初开发的软件。
在一项采用灰色区域分析的训练研究中,HCC-Scope对非HCC和HCC进行鉴别诊断的敏感性、特异性、阳性预测值(PPV)和阴性预测值(NPV)均为100%。在验证研究中也表现出色(采用灰色区域分析时,敏感性为95.0%,特异性为100%,PPV为100%,NPV为97.1%;不采用灰色区域分析时,敏感性为95.2%,特异性为100%,PPV为100%,NPV为97.1%)。HCC-Scope的敏感性(85.3%)和特异性(85.1%)显著高于甲胎蛋白(AFP)水平、AFP-L3水平、异常凝血酶原(DCP)水平以及性别-年龄-AFP-L3-AFP-DCP(GALAD)评分。
HCC-Scope能够准确鉴别非HCC的NASH和NASH-HCC,包括极早期NASH-HCC。