Friedrich-Rust M, Lupsor M, de Knegt R, Dries V, Buggisch P, Gebel M, Maier B, Herrmann E, Sagir A, Zachoval R, Shi Y, Schneider M D, Badea R, Rifai K, Poynard T, Zeuzem S, Sarrazin C
Department of Internal Medicine 1, J. W. Goethe-University Hospital, Frankfurt, Germany.
Department of Ultrasound, University of Medicine and Pharmacy, Cluj-Napoca, Romania.
Ultraschall Med. 2015 Jun;36(3):239-47. doi: 10.1055/s-0034-1398987. Epub 2015 May 13.
The aim of the present prospective European multicenter study was to demonstrate the non-inferiority of point shear wave elastography (pSWE) compared to transient elastography (TE) for the assessment of liver fibrosis in patients with chronic hepatitis C.
241 patients with chronic hepatitis C were prospectively enrolled at 7 European study sites and received pSWE, TE and blood tests. Liver biopsy was performed with histological staging by a central pathologist. In addition, for inclusion of cirrhotic patients, a maximum of 10 % of patients with overt liver cirrhosis confirmed by imaging methods were allowed by protocol (n = 24).
Owing to slower than expected recruitment due to a reduction of liver biopsies, the study was closed after 4 years before the target enrollment of 433 patients with 235 patients in the 'intention to diagnose' analysis and 182 patients in the 'per protocol' analysis. Therefore, the non-inferiority margin was enhanced to 0.075 but non-inferiority of pSWE could not be proven. However, Paired comparison of the diagnostic accuracy of pSWE and TE revealed no significant difference between the two methods in the 'intention to diagnose' and 'per protocol' analysis (0.81 vs. 0.85 for F ≥ 2, p = 0.15; 0.88 vs. 0.92 for F ≥ 3, p = 0.11; 0.89 vs. 0.94 for F = 4, p = 0.19). Measurement failure was significantly higher for TE than for pSWE (p = 0.030).
Non-inferiority of pSWE compared to TE could not be shown. However, the diagnostic accuracy of pSWE and TE was comparable for the noninvasive staging of liver fibrosis in patients with chronic hepatitis C.
本项前瞻性欧洲多中心研究的目的是证明在评估慢性丙型肝炎患者的肝纤维化方面，点剪切波弹性成像（pSWE）相对于瞬时弹性成像（TE）的非劣效性。
241例慢性丙型肝炎患者在7个欧洲研究地点被前瞻性纳入研究，并接受了pSWE、TE检查及血液检测。由中心病理学家进行肝活检并进行组织学分期。此外，按照方案，为纳入肝硬化患者，允许最多10%经影像学方法确诊的显性肝硬化患者入组（n = 24）。
由于肝活检减少导致招募速度慢于预期，该研究在4年后关闭，未达到目标招募的433例患者，“意向性诊断”分析中有235例患者，“符合方案”分析中有182例患者。因此，非劣效性界值提高到0.075，但pSWE的非劣效性未得到证实。然而，pSWE和TE诊断准确性的配对比较显示，在“意向性诊断”和“符合方案”分析中，两种方法之间无显著差异（F≥2时，分别为0.81对0.85，p = 0.15；F≥3时，分别为0.88对0.92，p = 0.11；F = 4时，分别为0.89对0.94，p = 0.19）。TE的测量失败率显著高于pSWE（p = 0.030）。
未显示pSWE相对于TE的非劣效性。然而，在慢性丙型肝炎患者肝纤维化的无创分期中，pSWE和TE的诊断准确性相当。
