Screening of Patients With Hepatic Fibrosis or Cirrhosis B and C

Официальное название

Out-of-hospital Screening of Patients With Significant Hepatic Fibrosis or Cirrhosis and Viral Hepatitis B and C

Обзор

Regardless of its etiology (chronic hepatitis B or C, alcohol consumption, metabolic steatohepatitis, hemochromatosis, autoimmune liver disease), cirrhosis is a real public health issue. Cirrhosis is a chronic disease and can get complicated by liver cancer, digestive hemorrhage, or liver failure, which are responsible for morbidity and mortality. In France, cirrhosis prevalence is estimated at 700,000 patients and induce 16,000 deaths per year (10,000 liver cancer and 6,000 liver decompensation). In Ile-de-France area, cirrhosis prevalence is estimated at 130,000 cases, a lot of them are in Seine Saint Denis department due to precariousness. Hepatitis C virus can now be cured and hepatitis B treatment can suspend hepatitis B replication. All these treatments reduce liver complications but even after virological cure, cirrhosis requires dedicated long term management as well as alcoholic liver disease and metabolic steatohepatitis at cirrhosis stage. Periodic screening for complications and specific measures were defined by french HAS in 2007 (medication intake, dietary management and specific vaccinations), especially the performance of a semi-annual liver ultrasound for hepatocellular carcinoma (HCC) screening. Then, it seems essential to screen for patients with viral hepatitis and extensive fibrosis or cirrhosis in our department to achieve active and individualized management of this chronic liver disease, to reduce long term morbidity and mortality. The main aim of the study is to evaluate the prevalence of advanced liver fibrosis and viral infections B and C in the general population of Seine Saint Denis, using a dual screening method of TROD (rapid diagnostic orientation test) and FibroScan®, combined with a care pathway

Подробное описание

Targeted population

The targeted population will be users of one municipal health center visiting the municipal health center on a given day We will propose a screening for liver fibrosis using Fibroscan mini® and will propose rapid diagnostic orientation tests (TROD) for HCV and HBV viral infection, by a traveling physician Expérimental scheme

Proposal by the caregiver to each patient at the center :

* Fibroscan® * TROD VHC / VHB IF Fibroscan ≥ 9.6 KPa or positive HCV TROD or HBsAg positive THEN Suggested appointment Avicenne hospital hepatology consultation or Jean Verdier hepatology consultation

Вмешательства

• Диагностический тест TROD (rapid diagnostic orientation test) and FibroScan®
  Fast-track appointment at the hepatology consultation at Avicenne Hospital (Bobigny) or the hepatology consultation at Jean Verdier Hospital (Bondy) for any patient : * with Fibroscan® ≥ 9.6 KPa or * positive hepatitis C serology or * HBsAg positive

Первичные конечные точки

• Prevalence of significant hepatic fibrosis in the general population of Seine Saint Denis [Срок оценки: Two year of inclusion period]

Вторичные конечные точки (7)

• Chronic hepatitis B prevalence [Срок оценки: Two year of inclusion period]
• Chronic hepatitis C prevalence [Срок оценки: Two year of inclusion period]
• Proportion of eligible patients for management of viral hepatitis B and C [Срок оценки: Two year of inclusion period]
• Prevalence of other causes of chronic liver disease (alcohol and NASH) [Срок оценки: Two year of inclusion period]
• Proportion of patients managed in hepatology department after screening for significant fibrosis [Срок оценки: Two year of inclusion period]
• Prevalence of confirmed significant liver fibrosis in patients referred to hepatology consultation [Срок оценки: Two years of inclusion period]
• Proportion of patients with ultrasound signs of cirrhosis and hepatocellular carcinoma among patients referred to hepatology consultation (managed according to current hepatology guidelines). [Срок оценки: Two years of inclusion period]

Критерии участия

Критерии включения

• Age≥18 years
• Collection of signed consent
• Patients affiliated to a Social Security System

Критерии исключения

• Pregnancy or breastfeeding
• Subjects under AME
• Persons under court protection
• Guardianship or curatorship,
• Safeguard of justice
• Persons under psychiatric care without their consent
• Persons admitted to a health or social institution for purposes other than research,
• Patients of full age under legal protection (guardianship or curatorship)
• Persons unable to express their consent.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 2 центра

• Avicenne Hospital — Bobigny
• Hepatology department -Hospital Avicenne — Bobigny

Публикации

• Marshall AD, Micallef M, Erratt A, Telenta J, Treloar C, Everingham H, Jones SC, Bath N, How-Chow D, Byrne J, Harvey P, Dunlop A, Jauncey M, Read P, Collie T, Dore GJ, Grebely J. Liver disease knowledge and acceptability of non-invasive liver fibrosis assessment among people who inject drugs in the drug and alcohol setting: The LiveRLife Study. Int J Drug Policy. 2015 Oct;26(10):984-91. doi: 10.10 PMID 26256938
• Matthews K, MacGilchrist A, Coulter-Smith M, Jones J, Cetnarskyj R. A nurse-led FibroScan(R) outreach clinic encourages socially deprived heavy drinkers to engage with liver services. J Clin Nurs. 2019 Feb;28(3-4):650-662. doi: 10.1111/jocn.14660. Epub 2018 Sep 24. PMID 30182502
• Chevaliez S, Pawlotsky JM. New virological tools for screening, diagnosis and monitoring of hepatitis B and C in resource-limited settings. J Hepatol. 2018 Oct;69(4):916-926. doi: 10.1016/j.jhep.2018.05.017. Epub 2018 May 23. PMID 29800630
• Debette-Gratien M, Francois S, Chevalier C, Alain S, Carrier P, Rigaud C, Abraham B, Burgevin AL, Courat L, Debenes B, Koffi J, Caux-Nussbaum E, Zattoni-Leroy J, Feuillet-Sow G, Dumont Q, Nubukpo P, Loustaud-Ratti V. Towards hepatitis C elimination in France: Scanvir, an effective model to test and treat drug users on dedicated days. J Viral Hepat. 2023 Apr;30(4):355-361. doi: 10.1111/jvh.13798. E PMID 36597183
• Ganne-Carrie N, Layese R, Bourcier V, Cagnot C, Marcellin P, Guyader D, Pol S, Larrey D, de Ledinghen V, Ouzan D, Zoulim F, Roulot D, Tran A, Bronowicki JP, Zarski JP, Riachi G, Cales P, Peron JM, Alric L, Bourliere M, Mathurin P, Blanc JF, Abergel A, Serfaty L, Mallat A, Grange JD, Attali P, Bacq Y, Wartelle C, Dao T, Benhamou Y, Pilette C, Silvain C, Christidis C, Capron D, Bernard-Chabert B, Zu PMID 27348075
• European Association for the Study of the Liver. EASL Clinical Practice Guidelines on non-invasive tests for evaluation of liver disease severity and prognosis - 2021 update. J Hepatol. 2021 Sep;75(3):659-689. doi: 10.1016/j.jhep.2021.05.025. Epub 2021 Jun 21. PMID 34166721

Идентификаторы

NCT: NCT06755632 · APHP240250

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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