Non-invasive tests (aspartate aminotransferase-to-platelet ratio index [APRI] and transient elastography [FibroScan]) were recommended in the 2015 WHO guidelines to guide treatment decisions in people with chronic hepatitis B. We updated the systematic review and meta-analysis that informed the 2015 guidelines to inform new cutoffs for non-invasive tests for the diagnosis of significant fibrosis and cirrhosis for the 2024 WHO guidelines for chronic hepatitis B.

We searched PubMed (MEDLINE), Embase, and Science Citation Index Expanded (Web of Science) for studies published in any language between Jan 1, 2014, and Feb 15, 2023. We included all studies that reported cross-sectional data on the staging of fibrosis or cirrhosis with APRI, Fibrosis-4 (FIB-4), and FibroScan compared with liver biopsy as the reference standard in people with chronic hepatitis B. We excluded studies in which the maximum interval between liver biopsy and non-invasive fibrosis test was more than 6 months; that reported on fewer than ten patients with advanced fibrosis or cirrhosis; that were done exclusively in children; and did not report diagnostic accuracy across our prespecified ranges of test cutoffs. The results of this updated search were collated with the meta-analysis that informed the 2015 guidelines. Outcomes of interest were the sensitivity and specificity of non-invasive tests using defined index test cutoffs for detecting significant fibrosis (≥F2), advanced fibrosis (≥F3), and cirrhosis (F4) based on the METAVIR staging system. We performed meta-analyses using a bivariate random-effects model.

Of 19 933 records identified by our search strategy, 195 were eligible for our systematic review and combined with the 69 studies from the previous meta-analysis to total 264. Two studies were at low risk of bias, 31 studies had unclear risk of bias, and 231 studies had a high risk of bias. Of these 264, 211 studies with 61 665 patients were used in the meta-analysis. For the diagnosis of significant fibrosis (≥F2), sensitivity and specificity were 72·9% (95% CI 70·2-75·5) and 64·7% (95% CI 61·0-68·2) for the APRI low cutoff (>0·3 to 0·7), 30·5% (23·7-38·3) and 92·3% (89·3-94·6) for the APRI high cutoff (>1·3 to 1·7), and 75·1% (72·2-77·7) and 79·3% (76·2-82·2) for FibroScan (>6·0 to 8·0 kPa), respectively. For the diagnosis of cirrhosis (F4), sensitivity and specificity were 59·4% (53·2-65·2) and 73·9% (70·1-77·4) for the APRI low cutoff (>0·8 to 1·2), 30·2% (24·2-36·9) and 88·2% (85·4-90·6) for the APRI high cutoff (>1·8 to 2·2), and 82·6% (77·8-86·5) and 89·0% (86·3-91·2) for FibroScan (>11·0 to 14·0 kPa), respectively. Using a hypothetical population of 1000 unselected patients with chronic hepatitis B with a 25% prevalence of significant fibrosis (≥F2), the APRI low cutoff for significant fibrosis (≥F2) would result in 262 (26·2%) false positives but only 68 (6·8%) false negatives. The FibroScan cutoff would result in 158 (15·8%) false positives and 63 (6·3%) false negatives. In a population with a 5% prevalence of cirrhosis (F4), the APRI low cutoff for cirrhosis (F4) would result in 247 (24·7%) false positives and 21 (2·1%) false negatives and the FibroScan cutoff would result in 105 (10·5%) false positives and nine (0·9%) false negatives.

These findings have informed new thresholds of APRI and FibroScan for diagnosis of significant fibrosis and cirrhosis in the 2024 WHO guidelines on chronic hepatitis B, with an APRI score greater than 0·5 or a FibroScan value greater than 7·0 kPa considered to identify most adults with significant fibrosis (≥F2) and an APRI score greater than 1·0 or a FibroScan value greater than 12·5 kPa to identify most adults with cirrhosis (F4). These patients are a priority for antiviral treatment.

WHO.

This review evaluated the diagnostic effectiveness of various ultrasound (US) methods compared to liver biopsy.

To determine the diagnostic accuracy of US techniques in assessing liver fibrosis and steatosis in adults, using the area under the receiver operating characteristic curve (AUROC) as the standard measure.

The review included original retrospective or prospective studies published in the last three years in peer-reviewed medical journals, that reported AUROC values. Studies were identified through PubMed searches on January 3 and April 30, 2024. Quality was assessed using the QUADAS-2 tool. Results were tabulated according to the diagnostic method and the type of liver pathology.

The review included 52 studies. For liver fibrosis detection, 2D-shear wave elastography (SWE) AUROCs ranged from 0.54 to 0.994, showing better accuracy for advanced stages. Modifications, including 2D-SWE with propagation map guidance and supersonic imagine achieved AUROCs of 0.84 to nearly 1.0. point SWE and classical SWE had AUROCs of 0.741-0.99, and 0.507-0.995, respectively. Transient elastography (TE), visual TE, vibration-controlled TE (VCTE), and FibroTouch reported AUROCs close to 1.0. For steatosis, VCTE with controlled attenuation parameter showed AUROCs up to 0.89 (for ≥ S1), acoustic radiation force impulse ranged from 0.762 to 0.784, US attenuation parameter from 0.88 to 0.93, and normalized local variance measurement from 0.583 to 0.875. Most studies had a low risk of bias across all or most domains, but evidence was limited by variability in study quality and small sample sizes. Innovative SWE variants were evaluated in a single study.

Modern US techniques can serve as effective noninvasive diagnostic tools for liver fibrosis and steatosis, with the potential to reduce the reliance on biopsies.

Transient elastography (TE), shear wave elastography, and/or magnetic resonance elastography (MRE), each providing liver stiffness measurement (LSM), are the most studied imaging-based noninvasive liver disease assessment (NILDA) techniques. To support the American Association for the Study of Liver Diseases guidelines on NILDA, we summarized the evidence on the accuracy of these LSM methods to stage liver fibrosis (F).

A comprehensive search for studies assessing LSM by TE, shear wave elastography, or MRE for the identification of significant fibrosis (F2-4), advanced fibrosis (F3-4), or cirrhosis (F4), using histopathology as the standard of reference by liver disease etiology in adults or children from inception to April 2022 was performed. We excluded studies with <50 patients with a single disease entity and mixed liver disease etiologies (with the exception of HCV/HIV coinfection). Out of 9447 studies, 240 with 61,193 patients were included in this systematic review. In adults, sensitivities for the identification of F2-4 ranged from 51% to 95%, for F3-4 from 70% to 100%, and for F4 from 60% to 100% across all techniques/diseases, whereas specificities ranged from 36% to 100%, 74% to 100%, and 67% to 99%, respectively. The largest body of evidence available was for TE; MRE appeared to be the most accurate method. Imaging-based NILDA outperformed blood-based NILDA in most comparisons, particularly for the identification of F3-4/F4. In the pediatric population, imaging-based NILDA is likely as accurate as in adults.

LSM from TE, shear wave elastography, and MRE shows acceptable to outstanding accuracy for the detection of liver fibrosis across various liver disease etiologies. Accuracy increased from F2-4 to F3-4 and was the highest for F4. Further research is needed to better standardize the use of imaging-based NILDA, particularly in pediatric liver diseases.

Blood-based biomarkers have been proposed as an alternative to liver biopsy for noninvasive liver disease assessment in chronic liver disease. Our aims for this systematic review were to evaluate the diagnostic utility of selected blood-based tests either alone, or in combination, for identifying significant fibrosis (F2-4), advanced fibrosis (F3-4), and cirrhosis (F4), as compared to biopsy in chronic liver disease.

We included a comprehensive search of databases including Ovid MEDLINE(R), EMBASE, Cochrane Database, and Scopus through to April 2022. Two independent reviewers selected 286 studies with 103,162 patients. The most frequently identified studies included the simple aspartate aminotransferase-to-platelet ratio index and fibrosis (FIB)-4 markers (with low-to-moderate risk of bias) in HBV and HCV, HIV-HCV/HBV coinfection, and NAFLD. Positive (LR+) and negative (LR-) likelihood ratios across direct and indirect biomarker tests for HCV and HBV for F2-4, F3-4, or F4 were 1.66-6.25 and 0.23-0.80, 1.89-5.24 and 0.12-0.64, and 1.32-7.15 and 0.15-0.86, respectively; LR+ and LR- for NAFLD F2-4, F3-4, and F4 were 2.65-3.37 and 0.37-0.39, 2.25-6.76 and 0.07-0.87, and 3.90 and 0.15, respectively. Overall, the proportional odds ratio indicated FIB-4 <1.45 was better than aspartate aminotransferase-to-platelet ratio index <0.5 for F2-4. FIB-4 >3.25 was also better than aspartate aminotransferase-to-platelet ratio index >1.5 for F3-4 and F4. There was limited data for combined tests.

Blood-based biomarkers are associated with small-to-moderate change in pretest probability for diagnosing F2-4, F3-4, and F4 in viral hepatitis, HIV-HCV coinfection, and NAFLD, with limited comparative or combination studies for other chronic liver diseases.

Radiological imaging is crucial in modern clinical practice and requires thorough and early training. An understanding of cross-sectional imaging is essential for effective interpretation of such imaging. This study examines the extent to which completing an undergraduate ultrasound course has positive effects on the development of visual-spatial ability, knowledge of anatomical spatial relationships, understanding of radiological cross-sectional images, and theoretical ultrasound competencies.

This prospective observational study was conducted at a medical school with 3rd year medical students as part of a voluntary extracurricular ultrasound course. The participants completed evaluations (7-level Likert response formats and dichotomous questions "yes/no") and theoretical tests at two time points (T1 = pre course; T2 = post course) to measure their subjective and objective cross-sectional imaging skills competencies. A questionnaire on baseline values and previous experience identified potential influencing factors.

A total of 141 participants were included in the study. Most participants had no previous general knowledge of ultrasound diagnostics (83%), had not yet performed a practical ultrasound examination (87%), and had not attended any courses on sonography (95%). Significant subjective and objective improvements in competencies were observed after the course, particularly in the subjective sub-area of "knowledge of anatomical spatial relationships" (p = 0.009). Similarly, participants showed improvements in the objective sub-areas of "theoretical ultrasound competencies" (p < 0.001), "radiological cross-section understanding and knowledge of anatomical spatial relationships in the abdomen" (p < 0.001), "visual-spatial ability in radiological cross-section images" (p < 0.001), and "visual-spatial ability" (p = 0.020).

Ultrasound training courses can enhance the development of visual-spatial ability, knowledge of anatomical spatial relationships, radiological cross-sectional image understanding, and theoretical ultrasound competencies. Due to the reciprocal positive effects of the training, students should receive radiology training at an early stage of their studies to benefit as early as possible from the improved skills, particularly in the disciplines of anatomy and radiology.

The aim of this study is to assess the agreement and performance of visual transient elastography (ViTE), sound touch elastography (STE), and sound touch quantification (STQ) for liver fibrosis staging using transient elastography (TE) as a standard. We finally enrolled 252 subjects with chronic liver disease (CLD) who underwent ViTE, STE, STQ, and TE examinations simultaneously in our hospital from October 2022 to July 2023. We evaluated the correlation and agreement between various technologies. And also evaluated the performances and optimal cutoffs of ViTE, STE, and STQ . The correlation coefficients of ViTE and TE, STE and TE, STQ and TE were 0.863, 0.709, and 0.727, respectively. The ICC among ViTE, STE, STQ, and TE was 0.911. The area under the receiver operating characteristics (AUROCs) of ViTE, STE, and STQ for detection of TE of ≥5 kPa, ≥10 kPa, ≥15 kPa, and ≥20 kPa were 0.867, 0.771, 0.804; 0.972, 0.935, 0.933; 0.998, 0.973, 0.968; and 1.000, 0.960, 0.954, respectively. The AUROCs of ViTE for detection of lower stages (TE≥5 kPa and ≥10 kPa) were significantly higher than STE and STQ in the overall cohort (ViTE vs. STE: Z  = 2.766, for TE ≥5 kPa; ViTE vs. STE: Z  = 2.145, ; ViTE vs. STQ: Z  = 2.587, for TE ≥10 kPa) (all P < 0.05). These methods all have coincided with performance in more advanced stages (TE ≥15 kPa and ≥20 kPa) (all P  > 0.05). These methods showed excellent correlation and agreement. ViTE performance in more advanced fibrosis differentiation is comparable to the STE and STQ while ViTE is more accurate than STE and STQ to identify patients with mild CLD stage, and can more effectively rule out compensated advanced CLD.

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a new nomenclature proposed in 2023. We aimed to compare the diagnostic efficacy of noninvasive tests (NITs) for advanced fibrosis under different nomenclatures in patients with chronic hepatitis B (CHB). A total of 844 patients diagnosed with CHB and concurrent steatotic liver disease (SLD) by liver biopsy were retrospectively enrolled and divided into four groups. The performances of fibrosis-4 (FIB-4), gamma-glutamyl transpeptidase to platelet ratio index (GPRI), aspartate aminotransferase to platelet ratio index (APRI), and liver stiffness measurement (LSM) were compared among the four groups. The four NITs showed similar diagnostic efficacy for nonalcoholic fatty liver disease (NAFLD), MASLD, and metabolic dysfunction-associated fatty liver disease (MAFLD) in patients with CHB with advanced fibrosis. LSM showed the most stable accuracy for NAFLD (AUC = 0.842), MASLD (AUC = 0.846), and MAFLD (AUC = 0.863) compared with other NITs (p < 0.05). Among the four NITs, APRI (AUC = 0.841) and GPRI (AUC = 0.844) performed best in patients with CHB & MetALD (p < 0.05). The cutoff value for GPRI in patients with CHB & MetALD was higher than that in the other three groups, while further comparisons of NITs at different fibrosis stages showed that the median GPRI of CHB & MetALD (1.113) at F3-4 was higher than that in the CHB & MASLD group (0.508) (p < 0.05). Current NITs perform adequately in patients with CHB and SLD; however, alterations in cutoff values for CHB & MetALD need to be noted.

To evaluate the diagnostic performance of dual elastography (dual-elasto) in continuous differentiation of liver fibrosis and inflammation in a large prospective cohort of patients with chronic HBV.

Adults with positive HBsAg for at least 6 months were recruited from 12 medical centers. Participants underwent dual-elasto evaluations. Biopsy was performed 3 days after dual-elasto examination. Four logistic regression models were trained and strung together into series models. Decision trees based on the series models were performed to achieve continuous differentiation of liver fibrosis and inflammation. The influence of inflammation on the fibrosis stage was also evaluated. A total of 560 patients were included in the training set and 240 in the validation set. Areas under the receiver operating characteristic curve of the series model were 0.82, 0.86, 0.93, and 0.96 to predict ≥F1, ≥F2, ≥F3, and F4 in the validation set, which were significantly higher than those of serum markers and shear wave elastography (all p < 0.05), except for the ≥ F1 levels ( p = 0.09). The AUCs of the series model were 0.93, 0.86, 0.95, and 0.84 to predict inflammation stages ≥G1, ≥G2, ≥G3, and G4, respectively. Decision trees realized 5 continuous classifications of fibrosis and inflammation. Inflammation could enhance the mild fibrosis stage classification while showing limited influences on severe fibrosis or cirrhosis diagnosis.

Dual-elasto demonstrated high performance in the continuous discrimination of fibrosis and inflammation in patients with HBV and could be used to diagnose mild fibrosis without the influence of inflammation.

Heart failure (HF) can damage various organs, including the liver, a phenomenon known as "cardiohepatic syndrome." The latter is characterized by liver congestion and hepatic artery hypoperfusion, which can lead to liver damage. In this study, we aimed to assess liver damage quantitatively in chronic HF (CHF) with sound touch elastography (STE). A total of 150 subjects were enrolled, including HF with reduced ejection fraction (HFrEF) groups (left ventricular ejection fraction ≤40%, n = 45), HF with mildly reduced ejection fraction (HFmrEF) groups (left ventricular ejection fraction between 41% and 49%, n = 40), and right-sided HF (RHF) groups (n = 25); normal groups (n = 40). Liver stiffness measurement (LSM) was performed in all subjects by STE. The other hepatic parameters were also measured. The LSM was 5.4 ± 1.1 kPa in normal subjects and increased slightly to 5.9 ± 0.7 kPa in patients with HFmrEF. However, the HFrEF and RHF groups had significantly higher LSMs of 8.4 ± 2.0 kPa and 10.3 ± 2.7 kPa, respectively. The LSM of HFrEF was significantly higher than that of HFmrEF, whereas the increase in LSM in patients with RHF was significant relative to HFmrEF and HFrEF. In addition, the other parameters showed abnormal values in only RHF and HFrEF. In conclusion, STE is a useful clinical technique for the noninvasive evaluation of liver stiffness associated with CHF, which could help patients with CHF manage their treatment regimens.

Liver biopsy was considered the gold standard for diagnosing liver fibrosis; however, with advancements in medical technology and increasing awareness of potential complications, the reliance on liver biopsy has diminished. Ultrasound is gaining popularity due to its wider availability and cost-effectiveness. This study examined the machine learning / deep learning (ML/DL) models for non-invasive liver fibrosis classification from ultrasound.

Following the preferred reporting items for systematic reviews and meta-analyses (PRISMA) protocol, we searched five academic databases using the query. We defined population, intervention, comparison, outcomes, and study design (PICOS) framework for the inclusion. Furthermore, Joana Briggs Institute (JBI) checklist for analytical cross-sectional studies is used for quality assessment.

Among the 188 screened studies, 17 studies are selected. The methods are categorized as off-the-shelf (OTS), attention, generative, and ensemble classifiers. Most studies used OTS classifiers that combined pre-trained ML/DL methods with radiomics features to determine fibrosis staging. Although machine learning shows potential for fibrosis classification, there are limited external comparisons of interventions and prospective clinical trials, which limits their applicability.

With the recent success of ML/DL toward biomedical image analysis, automated solutions using ultrasound are developed for predicting liver diseases. However, their applicability is bounded by the limited and imbalanced retrospective studies having high heterogeneity. This challenge could be addressed by generating a standard protocol for study design by selecting appropriate population, interventions, outcomes, and comparison.

In this study, we used the recently developed ultrasound elastography techniques sound touch elastography (STE) and sound touch quantification (STQ) to quantify portal hypertension (PHT) severity in a rat model of carbon tetrachloride (CCl₄ )-induced cirrhotic PHT.

In total, 60 rats were used. Various degrees of PHT were established. Liver and spleen stiffness were measured by STE (L-STE and S-STE, respectively) and STQ (L-STQ and S-STQ, respectively). We measured portal pressure (PP) after ultrasonographic examination. The performance of the STE and STQ parameters in the identification of PHT was evaluated using receiver operating characteristic (ROC) analyses.

Liver and spleen stiffness measurements obtained with STE and STQ correlated positively with the PP (r = 0.566-0.882, all P < .001). The areas under ROC curves for L-STE, S-STE, L-STQ, and S-STQ values were 0.931 (95% confidence interval [CI], 0.847-1.000), 0.982 (95% CI, 0.956-1.000), 0.796 (95% CI, 0.680-0.912), and 0.925 (95% CI, 0.858-0.993), respectively, for PP ≥5 mmHg; 0.937 (95% CI, 0.865-1.000), 0.938 (95% CI, 0.864-1.000), 0.967 (95% CI, 0.923-1.000), and 0.960 (95% CI, 0.897-1.000), respectively, for PP ≥10 mmHg; and 0.954 (95% CI, 0.897-1.000), 0.790 (95% CI, 0.652-0.928), 0.808 (95% CI, 0.680-0.935), and 0.740 (95% CI, 0.595-0.885), respectively, for PP ≥12 mmHg.

STE and STQ are reliable noninvasive tools for the assessment of PHT severity, especially for PP ≥10 mmHg, in a rat model of CCl₄ -induced cirrhotic PHT.

With the rapid development of shear wave elastography technology, the clinical application prospect of two-dimensional shear wave elastography (2D SWE) for non-invasive monitoring of liver fibrosis is extremely promising. This study aimed to evaluate the diagnostic performance of ElastQ, a noval 2D SWE method, in the staging of liver fibrosis in patients with chronic hepatitis B with histopathological results as the reference standard.

Between August 2020 and December 2021, a prospective multicenter study of 602 consecutive patients with chronic hepatitis B was conducted in 14 hospitals. All patients underwent liver biopsy and 2D SWE examination. The patients were divided into a training cohort and a validation cohort. The area under the receiver operating characteristic curve (AUROC) was calculated, and the optimal cut-off values for ElastQ were obtained.

Overall, 2D SWE values showed a strong correlation with fibrosis stage (r=0.71, P<0.001). In the training cohort, the AUROCs of ElastQ for diagnosing fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 0.817 [95% confidence interval (CI): 0.777-0.853), 0.887 (95% CI: 0.852-0.915), 0.912 (95% CI: 0.881-0.937), and 0.832 (95% CI: 0.793-0.866)], respectively. In the validation cohort, the AUROCs of ElastQ for diagnosing fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 0.807 (95% CI: 0.742-0.861), 0.868 (95% CI: 0.810-0.914), 0.855 (95% CI: 0.796-0.903), and 0.851 (95% CI: 0.791-0.900), respectively. The optimal liver stiffness cut-off values for the identification of fibrosis stages ≥S1, ≥S2, ≥S3, and S4 were 5.72 kPa (sensitivity: 78%, specificity: 70%), 6.85 kPa (sensitivity: 77%, specificity: 86%), 7.43 kPa (sensitivity: 80%, specificity: 86%), and 8.03 kPa (sensitivity: 81%, specificity: 73%), respectively.

Two-dimensional SWE can accurately stage liver fibrosis in patients with chronic hepatitis B.

This study aimed to quantitatively assess the quality of levator ani muscle (LAM) using shear wave elastography (SWE) and to evaluate the association between the elasticity of LAM and stress urinary incontinence (SUI). The study population included 32 women with SUI and 34 women with normal pelvic support. The thickness of LAM, bladder neck descent (BND), and urethral funneling (UF) were assessed by transperineal ultrasound. LAM elasticity was measured by SWE at rest and during the maximal Valsalva maneuver. Age, menopause, BND, and UF showed a positive correlation with SUI. There was no significant between-group difference in the elastic modulus values of LAM at rest. The thickness of LAM in women with SUI was greater than that in control group at rest and during the maximal Valsalva maneuver (P < 0.001). The elastic modulus values of Emax and Emean were significantly increased from rest to the maximal Valsalva maneuver in all participants (56.24 vs 82.43 kPa and 47.92 vs 72.37 kPa, P < 0.001). The change of these variables from rest to the maximal Valsalva maneuver in the control group was more obvious than that in the SUI group (34.09 vs 17.87 kPa and 31.55 vs 16.82 kPa, P < 0.05). The elasticity of LAM, as quantified by SWE, may potentially be used as an index for predicting SUI.

Measurements of liver stiffness obtained with 2-dimensional shear wave elastography (2D-SWE) have been widely used to clinically assess liver fibrosis. However, differences between different 2D-SWE systems can lead to confusion when interpreting measurements. This study investigated the variability between a recently released sound touch elastography (STE) system and a supersonic shear imaging (SSI) system and assessed the degree of intersystem discrepancy using the different liver stiffness value (LSV) thresholds recommended by the Society of Radiologists in Ultrasound (SRU) for assessing liver fibrosis.

A total of 4,152 patients who had undergone STE and SSI on the same day were enrolled in this retrospective study. First, intrasystem agreement for STE and SSI was assessed. Then, intraclass correlation coefficients (ICCs) and the Bland-Altman method were used to assess intersystem variability for all cases, classified according to the thresholds recommended by the SRU. The effects of age, gender, and body-mass index (BMI) were evaluated using multivariate linear regression analysis and attributive intervals were computed for STE and SSI at each of the different thresholds.

The ICCs for STE and SSI intrasystem agreement were 0.94 [95% confidence interval (CI): 0.937-0.943; P<0.001] and 0.984 (95% CI: 0.984-0.985; P<0.001), respectively. The 95% limit of agreement (LOA) for all cases ranged from -6.96 to 7.44 kPa. The 95% LOA increased as the threshold values rose, and intersystem variability was obvious, even at the smallest threshold (the 95% LOA at values ≤5 kPa was -0.85 to 2.08 kPa, while that at values >17 kPa was -20.81 to 14.71 kPa). The adjusted R2 for age, gender, and BMI was only 0.018 (all P value <0.05).

There was clear variability between STE and SSI, in contrast with some previous studies with small sample sizes, and consistent with others. Intersystem variability increased with the elevation of the LSV thresholds recommended by the SRU. Gender and BMI had little effect on intersystem variability. Future research could compare STE and SSI in different liver diseases, assessing the feasibility of the SRU-recommended thresholds in proven pathologies and evaluating the test-retest repeatability.

To compare the performance of spleen stiffness measurement (SSM) and liver stiffness measurement (LSM) by sound touch elastography (STE) for the diagnosis of cirrhosis at different alanine aminotransferase (ALT) levels, and to compare the applicability and repeatability of SSM with LSM performed by STE, a new two-dimensional shear wave elastography technology.

This prospective multicenter study included 25 centers and recruited chronic hepatitis B (CHB) patients with liver biopsy between May 2018 and November 2019. All patients underwent LSM and SSM by STE. Success and reliability rates were calculated and compared. Intra-observer agreement was assessed using intraclass correlation coefficients (ICCs). Differences between areas under the receiver operating characteristic curves (AUCs) of LSMs and SSMs at different ALT levels were compared using the Delong test.

Among 603 CHB patients, the success and reliability rates of SSM were 94.53% (570/603) and 85.74% (517/603), respectively, which were similar to those of LSM (p > 0.05), respectively. The ICC for intra-observer agreements of SSM was 0.964 (p < 0.001). In the total cohort, ALT ≤ 2 × upper limit of normal (ULN) group, and A0-1 group, the AUCs of SSMs were significantly lower than those of LSMs for the diagnosis of cirrhosis (p < 0.001). In the ALT > 2 × ULN group and A2-3 group, the AUC of SSM improved and was not significantly different from that of LSM (p = 0.342, p = 0.510, respectively).

SSM by STE achieved applicability and repeatability equivalent to those of LSM. SSM might be a good substitute to LSM in patients with high ALT levels.

• Spleen stiffness measurement performed by sound touch elastography was proven to have similar applicability and repeatability to liver stiffness measurement in this prospective multicenter study. • Spleen stiffness measurement demonstrated a poorer diagnostic performance for cirrhosis compared with liver stiffness measurement in the total cohort and low ALT level group, yet it showed a similar diagnostic performance to liver stiffness measurement in patients with high ALT levels.