Department of Gastroenterology and Metabology, Ehime University Graduate School of Medicine, Toon, Ehime, Japan.
PLoS One. 2021 Feb 4;16(2):e0246315. doi: 10.1371/journal.pone.0246315. eCollection 2021.
Hepatic venous pressure gradient (HVPG) is the gold standard index for evaluating portal hypertension; however, measuring HVPG is invasive. Although transient elastography (TE) is the most common procedure for evaluating organ stiffness, accurate measurement of spleen stiffness (SS) is difficult. We developed a device to demonstrate the diagnostic precision of TE and suggest this technique as a valuable new method to measure SS.
Of 292 consecutive patients enrolled in this single-centre, translational, cross-sectional study from June through September in 2019, 200 underwent SS measurement (SSM) using an M probe (training set, n = 130; inspection set, n = 70). We performed TE with B-mode imaging using an ultrasound-fusion method, printed new devices with a three-dimensional printer, and attached the magnetic position sensor to the convex and M probes. We evaluated the diagnostic precision of TE to evaluate the risk of esophagogastric varices (EGVs).
The median spleen volume was 245 mL (range, 64-1,720 mL), and it took 2 minutes to acquire a B-mode image using the ultrasound-fusion method. The median success rates of TE were 83.3% and 57.6% in patients with and without the new device, respectively (p<0.001); it was 76.9% and 35.0% in patients with and without splenomegaly (<100 mL), respectively (p<0.001). In the prediction of EGVs, the areas under the receiver operating characteristic curve were 0.921 and 0.858 in patients with and without the new device, respectively (p = 0.043). When the new device was attached, the positive and negative likelihood ratios were 3.44 and 0.11, respectively. The cut-off value of SSM was 46.0 kPa. Data that were similar between the validation and training sets were obtained.
The SS can be precisely measured using this new device with TE and ultrasound-fusion method. Similarly, we can estimate the bleeding risk due to EGV using this method.
肝静脉压力梯度（HVPG）是评估门静脉高压的金标准指标；然而，测量 HVPG 具有侵入性。尽管瞬时弹性成像（TE）是评估器官硬度最常用的程序，但准确测量脾脏硬度（SS）很困难。我们开发了一种设备来证明 TE 的诊断精度，并建议将该技术作为测量 SS 的一种有价值的新方法。
在 2019 年 6 月至 9 月期间，我们对 292 名连续患者进行了这项单中心、转化、横断面研究，其中 200 名患者接受了 SS 测量（培训集，n=130；检验集，n=70）。我们使用超声融合方法进行 TE 并使用 B 模式成像，使用三维打印机打印新设备，并将磁位置传感器附接到凸面和 M 探头。我们评估了 TE 评估食管胃静脉曲张（EGV）风险的诊断精度。
脾脏体积中位数为 245 mL（范围，64-1720 mL），使用超声融合方法采集 B 模式图像需要 2 分钟。在有和没有新设备的患者中，TE 的中位成功率分别为 83.3%和 57.6%（p<0.001）；在脾脏肿大（<100 mL）的患者中，分别为 76.9%和 35.0%（p<0.001）。在 EGV 的预测中，有和没有新设备的患者的受试者工作特征曲线下面积分别为 0.921 和 0.858（p=0.043）。当新设备连接时，阳性和阴性似然比分别为 3.44 和 0.11。SSM 的截止值为 46.0 kPa。在验证集和训练集之间获得了相似的数据。
使用这种带有 TE 和超声融合方法的新设备可以精确测量 SS。同样，我们可以使用这种方法估计 EGV 引起的出血风险。
