Prognostic Performance of Liver Stiffness Measurements in Primary Sclerosing Cholangitis: The Prospective FICUS cohort

Gastroenterology. 2026 Aug 4:S0016-5085(26)07125-8

Background & aims: Predicting outcomes of primary sclerosing cholangitis (PSC) by reliable and simple tools is an unmet need. Retrospective studies have suggested that liver stiffness measurement (LSM) by vibration-controlled transient elastography (FibroScan, Echosens) can predict outcomes. We aimed to validate the prognostic value of LSM statics and determine the relevance of LSM dynamics in a large, prospective, cohort study.

Methods: Clinical, biological, and LSM data of adult patients with uncomplicated PSC were prospectively recorded annually for 5 years. LSM was assessed continuously or according to 3 Baveno VII classes (<10 kPa, ≥10 to <15 kPa, and ≥15 kPa). The primary end point was transplant-free survival. Adjusted hazard ratios and 95% confidence intervals were determined using time-dependent multivariable Cox regression analyses. Effect of LSM change was evaluated using joint modeling. Progression was defined by a significantly positive individual LSM slope.

Results: The study analyzed 538 patients with at least 1 reliable LSM and follow-up available (median, 60.7 months; interquartile range [IQR], 48.6-66.0 months). Median baseline LSM was 7.6 kPa (IQR, 5.8-11.7 kPa). Nineteen patients died, and 72 received a transplant. Baseline LSM was strongly and independently linked to the risk of death or transplantation. For the groups 2.5 to <10 kPa, 10 to <15 kPa, and ≥15 kPa, the 5-year transplant-free survival was 93.9% (IQR, 90.3%-96.2%), 78.1% (IQR, 66.2%-86.3%), and 46.0% (IQR, 34.6%-56.7%), respectively. Progressors experienced worse transplant-free survival vs nonprogressors: adjusted hazard ratio of 3.12 (95% confidence interval, 1.55-6.24; P = .001). Each 1-kPa/y increment was associated with 18% increase in risk of death or transplantation.

Conclusions: This observational study validates the strong prognostic value of both static and dynamic LSM in PSC, as assessed by FibroScan. These results support the use of LSM as a risk stratification tool and potential surrogate end point in clinical trials.

Keywords: Elastography; FibroScan; Noninvasive; Time Course.