Two-step clinical care pathway to predict MASLD-related advanced fibrosis and long-term outcomes in type 2 diabetes

Background Current guidelines recommend a two-step approach for risk stratification of metabolic dysfunction-associated steatotic liver disease (MASLD), starting with Fibrosis-4 index (FIB-4) followed by liver stiffness measurement (LSM) using vibration-controlled transient elastography (VCTE). Objective To evaluate this approach for predicting advanced fibrosis and liver-related events (LREs) in patients with type 2 diabetes (T2D). Design A prospective liver biopsy cohort of T2D patients with histologically confirmed MASLD from seven centres in China was used to assess diagnostic performance for advanced fibrosis. The international VCTE-Prognosis cohort, including T2D patients with MASLD who underwent VCTE at 16 centres in the USA, Europe and Asia, with longitudinal follow-up, was used to assess LREs, defined as hepatic decompensation or hepatocellular carcinoma. Results 4781 participants were included. In the liver biopsy cohort (n=352; 22.2% with advanced fibrosis), applying LSM thresholds of <8 kPa and >12 kPa after FIB-4 classified patients into 63.4% low-risk, 9.4% intermediate-risk and 27.3% high-risk, with a correct classification rate of 71%. In the VCTE-Prognosis cohort (n=4429; median follow-up 51.3 (IQR 27.4–70.7) months), 140 (3.2%) patients developed LREs (110 (2.5%) with hepatic decompensation and 59 (1.3%) with hepatocellular carcinoma). The two-step approach classified 72.6%, 6.8% and 20.6% of patients into low-risk, intermediate-risk and high-risk groups, with corresponding 5-year cumulative LRE incidences of 0.7%, 0.9% and 11.8%. Refining classification of intermediate FIB-4 patients using LSM <10 kPa (low-risk) and >15 kPa (high-risk) reduced the intermediate-risk group to 5.6% while preserving predictive accuracy. Conclusion The non-invasive two-step approach of FIB-4 followed by LSM effectively stratifies MASLD-related advanced fibrosis and LREs risk in T2D. Applying LSM cut-offs of 10 and 15 kPa further optimises risk stratification for future LREs.

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Journal
Gut
Published
2026-01-21
DOI
https://doi.org/10.1136/gutjnl-2025-337506
Citations
2
Primary Topic
Liver Disease Diagnosis and Treatment
Type
article
Field-Weighted Citation Impact
63.04
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article

Two-step clinical care pathway to predict MASLD-related advanced fibrosis and long-term outcomes in type 2 diabetes

Amon Asgharpour, Gao‐Jun Teng, Yiling Li, W. F. Chan et al.
2 citations
Gut
Liver Disease Diagnosis and Treatment
63.04
article

Two-step clinical care pathway to predict MASLD-related advanced fibrosis and long-term outcomes in type 2 diabetes

Amon Asgharpour, Gao‐Jun Teng, Yiling Li, W. F. Chan, Kevin Teh, A. Nakajima, Bingtian Dong, Airong Hu, Salvatore Petta, Yuping Chen, Ying Shang, Xiao Han, Huapeng Lin, Qinglei Zeng, Sara Mahgoub, Calleja Jl, Elisabetta Bugianesi, Elba Llop, Manuel Romero-Gomez, Wei Gou, Victor de Lédinghen, Emmanuel Tsochatzis, Mandy Sau-Wai Chan, Hannes Hagström, Hye Won Lee, Ming-Hua Zheng, Hua Bian, Masato Yoneda, Marc de Saint-Loup, Grace Lai-Hung Wong, Terry Cheuk-Fung Yip, Chenlin Sun, Jérôme Boursier, Céline Fournier-Poizat, Xinrui Jin, Rocio Gallego-Durán, Xiao Liang, Wen-Yue Liu, Xiaolong Qi, Philip N Newsome, Jian-Gao Fan, Arun J Sanyal, Adrien Lannes, Vincent Wai-Sun Wong, Chuan Liu, Seung Up Kim, Carmen Lara-Romero, George Boon-Bee Goh, Laurent Castéra, Yameng Sun, Michelle Lai
article en
2 citations

Abstract

Background Current guidelines recommend a two-step approach for risk stratification of metabolic dysfunction-associated steatotic liver disease (MASLD), starting with Fibrosis-4 index (FIB-4) followed by liver stiffness measurement (LSM) using vibration-controlled transient elastography (VCTE). Objective To evaluate this approach for predicting advanced fibrosis and liver-related events (LREs) in patients with type 2 diabetes (T2D). Design A prospective liver biopsy cohort of T2D patients with histologically confirmed MASLD from seven centres in China was used to assess diagnostic performance for advanced fibrosis. The international VCTE-Prognosis cohort, including T2D patients with MASLD who underwent VCTE at 16 centres in the USA, Europe and Asia, with longitudinal follow-up, was used to assess LREs, defined as hepatic decompensation or hepatocellular carcinoma. Results 4781 participants were included. In the liver biopsy cohort (n=352; 22.2% with advanced fibrosis), applying LSM thresholds of <8 kPa and >12 kPa after FIB-4 classified patients into 63.4% low-risk, 9.4% intermediate-risk and 27.3% high-risk, with a correct classification rate of 71%. In the VCTE-Prognosis cohort (n=4429; median follow-up 51.3 (IQR 27.4–70.7) months), 140 (3.2%) patients developed LREs (110 (2.5%) with hepatic decompensation and 59 (1.3%) with hepatocellular carcinoma). The two-step approach classified 72.6%, 6.8% and 20.6% of patients into low-risk, intermediate-risk and high-risk groups, with corresponding 5-year cumulative LRE incidences of 0.7%, 0.9% and 11.8%. Refining classification of intermediate FIB-4 patients using LSM <10 kPa (low-risk) and >15 kPa (high-risk) reduced the intermediate-risk group to 5.6% while preserving predictive accuracy. Conclusion The non-invasive two-step approach of FIB-4 followed by LSM effectively stratifies MASLD-related advanced fibrosis and LREs risk in T2D. Applying LSM cut-offs of 10 and 15 kPa further optimises risk stratification for future LREs.

GutVol. 75(3)
University Hospitals Birmingham NHS Foundation Trust (GB), Beth Israel Deaconess Medical Center (US), Karolinska University Hospital (SE), Harvard University (US), Inserm (FR), Sun Yat-sen University (CN), Chinese University of Hong Kong (HK), Shanghai Jiao Tong University (CN), Virginia Commonwealth University (US), Yonsei University (KR), Anhui Medical University (CN), Université Paris Cité (FR), Singapore General Hospital (SG), Fudan University (CN), Wenzhou Medical University (CN), Hôpital Beaujon (FR), The Royal Free Hospital (GB), XinHua Hospital (CN), First Affiliated Hospital of Wenzhou Medical University (CN), Sir Run Run Shaw Hospital (CN), Karolinska Institutet (SE), Foundation for Liver Research (GB), University of Malaya (MY), Azienda Ospedaliera Citta' della Salute e della Scienza di Torino (IT), National Clinical Research Center for Digestive Diseases (CN), Shanghai Ninth People's Hospital (CN), Assistance Publique – Hôpitaux de Paris (FR), Ningbo No. 2 Hospital (CN), Hospital Universitario Puerta de Hierro Majadahonda (ES), Zhongda Hospital Southeast University (CN), Department of Health (ES), Department of Medical Sciences (RU), Zhongshan Hospital (CN), The First Affiliated Hospital, Sun Yat-sen University (CN), Instituto de Biomedicina de Sevilla (ES), First Affiliated Hospital of Anhui Medical University (CN), First Hospital of China Medical University (CN), First Affiliated Hospital of Zhengzhou University (CN), Qingdao Eighth People's Hospital (CN), NIHR Birmingham Biomedical Research Centre (GB), University College London (GB), Université d'Angers (FR), Universidad Autónoma de Madrid (ES), Southeast University (CN), Yokohama City University (JP), China Medical University (CN)
Openalex Percentile: Top 0%
Liver Disease Diagnosis and Treatment
63.04
DOISourceOpenAlex
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