Background Approaches to liver biopsy have changed over the past decade in patients with chronic liver disease. Aims We conducted a systematic review and meta-analysis on the incidence of all complications and technical failure associated with percutaneous liver biopsy. Methods We systematically searched PubMed and the Cochrane Library for cohort studies reporting on complications resulting from liver biopsy published between 2010 and 2020. Studies on participants of any age and sex, who underwent any percutaneous biopsy for non-focal liver disease, were selected. All events except mild pain, minor hematoma, vasovagal episodes, fever and fistula were defined as major complications. Random-effect model meta-analyses with and without covariates were performed, to examine the effect of publication year, patient characteristics, outcome collection, and biopsy type on incidences. Results We identified 30 studies reporting on complications resulting from percutaneous liver biopsy procedures (n = 64,356). Incidence of major complications was 2.44% (95% CI 0.85, 6.75), with mortality at 0.01% (95% CI 0.00, 0.11), hospitalization at 0.65% (95% CI 0.38, 1.11), major bleeding at 0.48% (95% CI 0.22, 1.06), and moderate/severe pain at 0.34% (95% CI 0.08, 1.37). Minor complications at 9.53% (95% CI 3.68, 22.5) were mainly pain at 12.9% (95% CI 5.34, 27.9). Technical failure was high at 0.91% (95% CI 0.27, 3.00). Decreasing patient age significantly increased incidence of hospitalization and major bleeding (P < 0.0001). Hospitalization incidence also significantly increased with disease severity. Conclusions Incidence of major (2.4%) and minor (9.5%) complications, and technical failure (0.91%) in percutaneous liver biopsies continues.

Bioelectrical impedance analysis (BIA) is a non-invasive technique that measures electrical resistance (R) and reactance (Xc), which are then used to calculate phase angle (PA). The aim of this pilot study was to assess whether BIA can differentiate between minimal and advanced hepatic fibrosis in patients with chronic hepatitis C (HCV) infection. Twenty patients with HCV participated in this study, and were divided into minimal (Metavir 1) and advanced (Metavir 3 or 4) fibrosis groups. We obtained BIA measurements (R and Xc) in several axes and calculated PA from each pair of measurements. We found no statistically significant differences between the two groups with respect to PA, R, or Xc for the whole body, the trunk or the right upper quadrant measurements in any axis. Mean whole body PA was 7.0 and 7.1 (P = 0.9) in the minimal and advanced fibrosis groups, respectively. Bioelectrical impedance analysis did not demonstrate the ability to distinguish between minimal and advanced degrees of hepatic fibrosis in patients with chronic HCV infection.

Background The rising prevalence of nonalcoholic fatty liver disease (NAFLD) and the more aggressive subtype, nonalcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure, and death. The current standard for diagnosing and staging liver disease is a liver biopsy, which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective, noninvasive diagnostic tool for these conditions. LiverMultiScan is one such promising tool that uses multi-parametric magnetic resonance imaging (mpMRI) to characterize liver tissue and to aid in the diagnosis and monitoring of liver diseases of various etiologies. Objective The primary objective of this trial (RADIcAL1) is to evaluate the cost-effectiveness of the introduction of LiverMultiScan as a standardized diagnostic test for liver disease in comparison to standard care for NAFLD, in different EU territories. Methods RADIcAL1 is a multi-center randomized control trial with 2 arms conducted in 4 European territories (13 sites, from across Germany, Netherlands, Portugal, and the United Kingdom). In total, 1072 adult patients with suspected fatty liver disease will be randomized to be treated according to the result of the mpMRI in the intervention arm, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. Patients in the control arm will be treated as per center guidelines for standard of care. The primary outcome for this trial is to compare the difference in the proportion of patients with suspected NAFLD incurring liver-related hospital consultations or liver biopsies between the study arms, from the date of randomization to the end of the study follow-up. Secondary outcomes include patient feedback from a patient satisfaction questionnaire, at baseline and all follow-up visits to the end of the study, and time, from randomization to diagnosis by the physician, as recorded at the final follow-up visit. Results This trial is currently open for recruitment. The anticipated completion date for the study is December 2020. Conclusions This randomized controlled trial will provide the evidence to accelerate decision making regarding the inclusion of mpMRI-based tools in existing NAFLD/NASH clinical care. RADIcAL1 is among the first and largest European health economic studies of imaging technologies for fatty liver disease. Strengths of the trial include a high-quality research design and an in-depth assessment of the implementation of the cost-effectiveness of the mpMRI diagnostic. If effective, the trial may highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary consultations and invasive diagnostic investigations, and demonstrate that including LiverMultiScan as a NAFLD diagnostic test may be cost-effective compared to liver-related hospital consultations or liver biopsies. Trial Registration ClinicalTrials.gov NCT03289897 https://clinicaltrials.gov/ct2/show/NCT03289897 International Registered Report Identifier (IRRID) DERR1-10.2196/19189

UNSTRUCTURED The rising prevalence of non-alcoholic fatty liver disease (NAFLD) and the more aggressive subtype, non-alcoholic steatohepatitis (NASH), is a global public health concern. Left untreated, NAFLD/NASH can lead to cirrhosis, liver failure and death. The current standard for diagnosing and staging liver disease is a liver biopsy which is costly, invasive, and carries risk for the patient. Therefore, there is a growing need for a reliable, feasible, and cost-effective non-invasive diagnostic tool for these conditions. LiverMultiScan is one such tool and uses multiparametric MRI (mpMRI) to characterise liver tissue and to aid in the diagnosis and monitoring of liver diseases of various aetiologies. RADIcAL1 is a multi-centre randomised control trial to investigate the use of mpMRI as a standardised diagnostic test for liver disease. Patients in the control arm will be treated as per centre guidelines. Patients in the study arm will be treated according to the result of the mpMRI, so that further diagnostic evaluation is recommended only when values for metrics of liver fat or fibro-inflammation are elevated. The primary objective of this study is evaluation of the cost-effectiveness of the use of mpMRI in the tertiary-referral hepatology centres making up this trial (three in European countries and 10 in the UK). The primary outcome for this trial is to evaluate the utility of mpMRI in reducing the burden of patients with suspected fatty liver disease that incur unnecessary additional liver-related hospital consultations and/or liver biopsies. The trial may therefore highlight the health economic burden on tertiary-referral hepatology clinics imposed by unnecessary clinical consultations and invasive investigations.

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