Introduction
Liver stiffness measurements has become a "gold standard" for liver fibrosis assessment. New techniques based on the same physical principles have become available, but little is known about their comparative efficacy, especially in subjects with non-alcoholic fatty liver disease.
Aims & Methods
Aim: to compare the data of liver stiffness measurement with the use of FibroScan 502 (EchoSens, France) and iLivTouch FT200 (Wuxi Hisky Medical Technologies Co., China) devices.
Method:
Subjects with non-alcoholic fatty liver disease (per EASL guidelines) who gave informed consent were eligible for the study (NCT05224037 at clinicaltrials.gov). All participants were examined on the same day with the use of both, iLivTouch FT200 (Wuxi Hisky Medical Technologies Co., China) (data are marked as LT) with a standard sensor, and Fibroscan 502 (EchoSens, France) with M or XL sensors depending on the patient's characteristics (FS). We compared the efficacy of examination and analyzed the results obtained with both devices depending on the stage of liver fibrosis. The null hypothesis was the absence of differences between the data obtained using both devices.
Results
The data of 105 people (58 women, mean age per group 52.8±12.6 years, BMI: 32.3±9.48 kg/m2) were available. Success rate for FS was 68.7 ± 29% compared to LT: 86.9±19%; p<0.001. In 5 patients, it was impossible to conduct examination with FS, while it was possible to obtained at least 10 measurements using LT (in all cases BMI was >35 kg/m2). In 1 case, it was not possible to obtain sufficient number of measurements with LT, although FS gave successful result.
There was significant direct correlation between the data of liver stiffness measurements obtained with both devices: Spearman rank R=0.56. However, comparison revealed significant difference in values: 9.6±6.6 kPa with LT vs 6.9±4.5 kPa using FS, p<0.0001.
In patients with NAFLD with advanced stages of liver fibrosis (F2+, n=29) the values of FS and LT were similar: 11.8±5.9 kPa for FS vs 13.9±7.9 kPa for LT, p=0.2. However, the values of liver stiffness differed significantly when subjects had milder stages (F0-1, n=71,) of liver fibrosis: 4.9±1.0 kPa for FS vs 7.4±3.0 kPa, p<0.001. The agreement in liver fibrosis stage assessment (using cut-off values provided by the manufacturers) were as follows: for F0 - 56.9%, for F1-42.9%, F2-43.8%, F3-66.7%, and F4-70% of cases.
Conclusion
The results of liver stiffness obtained with Fibroscan and iLivTouch correlate closely. However, the agreement between studied techniques in subjects with non-alcoholic fatty liver disease is low.To make the measurements obtained with iLivTouch more accurate it may be necessary to develop new cut-off values that corresponds with different stages of liver fibrosis.
This work was performed with financial support of Ministry of Science and Higher Education of Russia, research grant No. FGMF-2022–0005