Fibro Touch For The Diagnosis And Prognostic Assessment Of Hepatic Fibrosis In Primary Biliary Cholangitis

Background:Primary biliary cholangitis(PBC)is a slowly progressive disease with a natural course of 10-15 years,high-risk patients can progress rapidly to decompensated cirrhosis and even death.Previous studies have found that the more severe the degree of histological liver fibrosis,the worse the prognosis for patients with PBC;advanced liver fibrosis(pathological staging as bridging fibrosis or cirrhosis)is an independent risk factor for poor prognosis in PBC.Therefore,early diagnosis and correct assessment of liver fibrosis stage in clinical practice are important in understanding the extent of disease progression,deciding on treatment,and assessing patient prognosis.The FibroTouch(FT)is a device that combines transient elastography,2D Doppler ultrasound imaging and liver steatosis acquisition techniques,and is uniquely suited to assess the staging of liver fibrosis and predict patient prognosis.Only two small sample studies have evaluated the diagnostic efficacy of FT in PBC liver fibrosis,and the findings are inconsistent.It is unclear whether PBC disease characteristics influence FT liver stiffness measurements(LSM),reliable diagnostic cut-off values for PBC liver fibrosis are lacking and no studies have assessed the prognostic value of FT in patients with PBC.In 2021,the Baveno VII Working Group proposed for the first time the "Rule of 5 kPa",the "Relationship between LSM <10 kPa and prognosis" and the "A clinically significant decrease in LSM",these "new concepts" have yet to be validated in patients with PBC.Aims:1.To assess the diagnostic efficacy of FT in the diagnosis of liver fibrosis in PBC and define the optimal diagnostic threshold for each fibrosis stage.2.To assess the prognostic value of FT in PBC patients and to validate the "criteria" proposed by the Baveno VII Working Group.Methods:1.Retrospective analysis was performed on PBC patients who underwent FT test and pathology examination within one year before and after.The results of pathological examination were used as reference.Spearman rank correlation test was used to evaluate the correlation between FT-LSM and hepatic fibrosis stage.Receiver operating characteristic curve(ROC)and De Long test were used to compare the diagnostic efficacy of FT and serological fibrosis diagnosis model for different stages of liver fibrosis,and to determine the optimal cut-off value of FT for diagnosing each stage of fibrosis.2.Retrospective analysis of PBC patients who underwent FT testing in our center.The Cox model was used to determine the variables associated with the prognosis of PBC patients,and the hazard ratio(HR)was calculated.Kaplan-Meier(K-M)curves were drawn to verify the "5 kPa principle" and "clinically significant reduction of LSM".The optimal threshold for LSM progression rate was calculated using the R language "survival" software package,and "clinically significantly elevated LSM" was defined in patients with10≤LSM<15 kPa.Results:1.The diagnostic efficacy of FT for cirrhosis,advanced fibrosis and significant fibrosis was better than that of serological fibrosis diagnostic models(AAR index,Mayo score,APRI model and FIB-4 index).2.The diagnostic efficacy of combined serological diagnostic model was the same as that of FT alone in the evaluation of hepatic fibrosis;3.The optimal cut-off values of FT for the diagnosis of cirrhosis,advanced fibrosis and significant fibrosis were 16,12 and 10 kPa,respectively,and the areas under ROC curve were 0.862(0.801-0.923),0.805(0.756-0.855)and 0.764(0.712-0.815),respectively.4.The FT-LSM 5 kPa fraction(10-15-20 kPa)represents an increased risk of hepatopathy-related death,liver transplantation,or decompensated cirrhosis events.5.Clinically significant reductions in LSM,defined as at least a 20% reduction in liver hardness <20 kPa,or a reduction to less than 10 kPa,assessed at 6,12,and 24 months of FT,were associated with a significantly reduced risk of hepatopathy-related death,liver transplantation,or decompensated cirrhosis events in patients with PBC.6.Clinically significant increases in LSM,defined as at least a 20% increase in liver hardness or an increase of 15 kPa or more,assessed at 6,12,and 24 months of FT testing,were associated with a significantly increased risk of hepatology-related death,liver transplantation,or decompensated cirrhosis events in patients with PBC.Conclusions:FT can be a reliable means of assessing the extent of liver fibrosis in PBC,and can be used to monitor the disease process and predict long-term prognosis in patients with PBC.