Development and Validation of a Radiomics Signature for Clinically Significant Portal Hypertension in Cirrhosis: A Prospective Multicenter Study

Clinically significant portal hypertension (CSPH) is associated with an incremental risk of esophageal varices and overt clinical decompensations. However, hepatic venous pressure gradient (HVPG) measurement, the gold standard for defining CSPH is invasive and impractical for routine clinical practice. This study aims to develop and validate a radiomics-based model as a noninvasive method for accurate detection of CSPH in cirrhosis. The prospective multicenter diagnostic trial (CHESS1701, ClinicalTrials.gov identifier: NCT03138915) involved 385 patients with cirrhosis from 5 liver centers in China between August 2016 and September 2017. Patients who had a HVPG measurement and contrast-enhanced CT within 14 days prior to the catheterization were collected. The noninvasive radiomics model, termed rHVPG for CSPH was developed based on CT images in a primary cohort that consisted of 222 consecutive patients and the diagnostic performance was prospectively assessed in 163 consecutive patients in 4 external validation cohorts. rHVPG showed a high diagnostic accuracy for detection of CSPH with a C-index of 0.849 (95%CI: 0.786-0.911). Application of rHVPG in 4 external prospective validation cohorts still gave excellent performance with the C-index of 0.889 (95%CI: 0.752-1.000, 0.800 (95%CI: 0.614-0.986), 0.917 (95%CI: 0.772-1.000), and 0.827 (95%CI: 0.618-1.000), respectively. Intraclass correlation coefficients for inter- and intra-observer agreement were 0.92-0.99 and 0.97-0.99, respectively. A novel radiomics signature was developed and prospectively validated as an accurate method for noninvasive detection of CSPH in cirrhosis. The tool of rHVPG assessment can facilitate the identification of CSPH rapidly when invasive transjugular procedure is not available.Trial Registration Number: ClinicalTrials.gov identifier: NCT03138915 Funding: This work was supported by the grants from National Natural Science Foundation of China (81600510, 81672725); Guangzhou Industry-Academia-Research Collaborative Innovation Major Project (201704020015); Beijing Municipal Administration of Hospitals Clinical Medicine Development of Special Funding (ZYLX201610), Beijing Municipal Administration of Hospitals’ Ascent Plan (DFL20151602), Application Research on Clinical Characteristics of the Capital (z161100000516197), Capital’s Funds for Health Improvement and Research (2018-1-2081).Conflict of Interest: No author has any potential conflict to disclose (financial, professional or personal) relevant to the manuscript.Ethical Approval Statement: The study was performed according to Helsinki declaration and approved by all institutional review board.