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临床试验/NCT07031089
NCT07031089尚未招募不适用

City-hospital Collaboration for the Early Screening of Hepatic Fibrosis in Primary Care: a Secondary Prevention Project in the Grenoble Health Basin

University Hospital, Grenoble0 个研究点目标入组 150 人开始时间: 2025年11月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
主要终点
Evaluation of managment of risk factors for significant liver fibrosis.

研究概览

简要总结

Cirrhosis and hepatocellular carcinoma (HCC) are responsible for 25,000 deaths per year in France. The main causes are excessive alcohol consumption, metabolic steatosis, and hepatitis B and C. Fibrosis, classified from F0 (absence of fibrosis) to F4 (cirrhosis), is the sole determinant of liver-related mortality, particularly from stage F3. The incidence of metabolic steatosis is increasing, associated with a rise in mortality from chronic liver diseases (CLD). CLDs, often asymptomatic, are diagnosed late, reducing patient survival. Recommendations exist for the screening of hepatic fibrosis in at-risk patients (alcohol, diabetes, metabolic syndrome). This screening relies on calculating the FIB-4 score (calculated from widely prescribed variables: AST, ALT, platelets, age), followed by Fibroscan® (a non-invasive test for hepatic fibrosis) if FIB-4 > 1.3.

A Fibroscan® result <8kPa excludes advanced fibrosis, while a result >9.6kPa suggests advanced fibrosis and ≥15kPa indicates cirrhosis. The appropriate care pathway includes a risk reduction program, a specialized consultation for patients with Fibroscan® ≥8kPa, and semi-annual screening for HCC in the case of cirrhosis. Indeed, it has been shown in a French cohort of patients with viral C cirrhosis that adherence to semi-annual screening is associated with better survival.

Eligible patients are primarily seen in primary care, and INCA has published a recommendation intended for general practitioners to improve the screening of fibrosis [13]. However, FIB-4 is poorly known among general practitioners [14], and access to Fibroscan® remains limited [15], hindering the implementation of the recommendations. Therefore, a care pathway has been established in the Grenoble area, initiated by Professor Costentin, allowing access to Fibroscan® for patients in primary care, starting from 2022 at the CHU. The objective is to evaluate the completion of the pathway, particularly the management of MCF risk factors and referral to specialized consultation for patients with Fibroscan® ≥8 kPa.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18 years or older
  • Having undergone a Fibroscan® at the CHU de Grenoble-Alpes , requested by a primary care practitioner (general practitioner, non-hospital diabetologist, Asalée nurse), as part of the screening recommendations for liver fibrosis in the case of a FIB4 score > 1.3
  • With a result ≥ 8kPa
  • Between January 2023 and January 2026

排除标准

  • Patients who have expressed their opposition to participating in the study
  • Patients under guardianship or deprived of liberty
  • Patients with a known chronic liver disease who are being monitored at the time of the Fibroscan® procedure

结局指标

主要结局

Evaluation of managment of risk factors for significant liver fibrosis.

时间窗: Up to 30 months

Proportion of patients with Fibroscan® ≥ 8kPa who received a specialized consultation in hepatogastroenterology in the year following the Fibroscan®

次要结局

  • Frequency of risk factors for liver fibrosis.(Up to 30 months)
  • Evaluation of managment of risk factors for significant liver fibrosis in chu Grenoble Alpes patients .(up to 30 months)
  • Evaluation of managment of risk factors for liver fibrosis.(Up to 30 months)
  • Evaluation of patients satisfaction after(Up to 30 months)
  • Evaluation of social determinals of health associated to the risks of advanced of liver fibrosis.(up to 30 months)
  • Evaluation of the proportion of patients who had at least one specialized consultation within 12 months.(up to 30 months)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

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