Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| On-call medical home (MMG) Clermont-Hérault | UNKNOWN |
| Medical office Montpeyroux | UNKNOWN |
| Medical office Clermont-Hérault | UNKNOWN |
| Medical office Aniane |
Not provided
Not provided
Not provided
Not provided
Improving the care of patients with liver diseases in primary care and will allow patients with chronic liver disease to benefit from a course appropriate care.
The prevalence of chronic liver diseases continues to increase on the one hand by the increase in non-alcoholic fatty liver disease (NAFLD) which affects 25% of the general population as well as the increased incidence of hepatocellular carcinoma in recent years. Screening for liver fibrosis in the general population represents a major public health issue.
The FIB-4 score is obtained by a blood test. This score combines age, measurement of ALT/ASAT (alanine aminotransferase / aspartate-aminotransferase) and platelet count. This score is sensitive for detecting advanced fibrosis liver and allows 71% of patients to avoid a liver biopsy.
Transient elastometry (Fibroscan®) is another very effective non-invasive assessment in the diagnosis of chronic liver diseases and hepatic fibrosis. It has already been demonstrated by several studies that combining several non-invasive fibrosis tests allows to improve the precision of the result.
The investigators hypothesize that offering an additional assessment by Fibroscan for patients screened by a blood test (FIB-4 Score) as possibly having advanced liver fibrosis (Score >1.3) will raise awareness among professional practitioners and the general population with chronic liver diseases and refine screening for chronic liver diseases.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Population with a chronic liver disease risk factor | Other | Patient aged ≥ 40 years, with no known liver disease, consulting a general practitioner and having at least one risk factor for chronic liver disease: risky consumption of alcoholic beverages according to the AUDIT questionnaire, the presence of a metabolic syndrome, diabetes or a risk factor for viral hepatitis B/D or C. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample then fibroscan | Diagnostic Test | The patient takes a blood test if none less than 6 months old is available, including a complete blood count (CBC) and a hepatic check. The FIB-4 score will be calculated from this blood test. If the result of the FIB-4 test is greater than 1.3 the person will be contacted by the SELHV (Service Expert de Lutte contre les Hépatites Virales) of the University Hospital of Montpellier in order to schedule, if she wishes, a second non-invasive screening examination of liver fibrosis by Fibroscan. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of the liver fibrosis screening acceptability (FIB-4) | percentage of patients who agreed to a FIB-4 blood test among all included patients offered screening. | During the inclusion assessment at day 1 (Visit 0) |
| Evaluation of the liver fibrosis screening acceptability (FIB-4 and Fibroscan) | percentage of patients who agreed to a FIB-4 blood test FIB-4 followed by Fibroscan (if FIB-4 score>1.3) among all included patients offered screening. | During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1) |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of advanced liver fibrosis by elastometry pulse (Fibroscan®) with a FIB-4 score>1.3 | If FIB-4 Score>1.3 a pulse elastometry (Fibroscan®) will be performed. A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis. | During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Magdalena MESZAROS, MD | University Hospital, Montpellier | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18395077 | Background | Friedrich-Rust M, Ong MF, Martens S, Sarrazin C, Bojunga J, Zeuzem S, Herrmann E. Performance of transient elastography for the staging of liver fibrosis: a meta-analysis. Gastroenterology. 2008 Apr;134(4):960-74. doi: 10.1053/j.gastro.2008.01.034. Epub 2008 Jan 18. | |
| 35120736 | Background | de Franchis R, Bosch J, Garcia-Tsao G, Reiberger T, Ripoll C; Baveno VII Faculty. Baveno VII - Renewing consensus in portal hypertension. J Hepatol. 2022 Apr;76(4):959-974. doi: 10.1016/j.jhep.2021.12.022. Epub 2021 Dec 30. |
| Label | URL |
|---|---|
| Recommandations pour le diagnostic et le suivi non-invasif des maladies chronique du foie, Association Française pour l'étude du foie. | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D065626 | Non-alcoholic Fatty Liver Disease |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Prevalence of excessive consumption of alcohol | Excessive alcohol consumption will be evaluated by the AUDIT-C questionnaire (Alcohol Use Disorders Identification Test) with a score ranging from 0 (lower risk) to 12 (higher risk of misuse), a score of > or = 3 for women and > or = 4 for men indicates misuse. | During the inclusion assessment at day 1 (Visit 0) |
| Prevalence of a history or drug use | Rate of participants with a history or current use of drugs among included patients. Answered by the patient face to face with the doctor. | During the inclusion assessment at day 1 (Visit 0) |
| The correlation between advanced liver fibrosis and risk factors for liver disease (presence of metabolic syndromes, viral hepatitis, alcool use disorders) | The correlation will be evaluated by the rate of patients with risk factors for liver disease and advanced fibrosis, among all those who underwent Fibroscan. A fibrotest measurement of ≥10 KPa (Kilopascals) or a score ≥F3 will be considered as advanced hepatic fibrosis The presence of metabolic syndrom if at least 3 of the following risk factors are present : arterial hypertension (≥ 130/85 mmHg), hypertriglyceridemia (≥ 1.7 mmol/L), low HDL-cholesterol (Men< 1 mmol/L; women < 1.3 mmol/L) , android obesity (≥ 102 cm men; ≥ 88 cm women) and fasting hyperglycemia (> 100 mg/dL) Presence of an alcohol use disorders : AUDIT-C questionnaire with a score of ≥ 3 for women and ≥ 4 for men indicates misuse. Presence of diabetes in medical records. Presence of hepatitis by using a serology blood test (Hepatitis C Virus : HCV RNA, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity). | During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1) |
| prevalence of viral hepatitis | Diagnosis of hepatitis by using a rapid diagnostic orientation test (TROD) by collecting of a drop of blood from the fingertip which is placed on a plate with a reactive solution in order to establish the presence of antigens and/or with a serology blood test (( Hepatitis C Virus : HCV RNA, HCV+, surface antigen of the hepatitis B virus : HBsAg, anti HBsAg, anti HBCAg, HBV DNA, HBeAg, anti HBeAg, Delta virus in case of hepatitis B positivity). Prevalence of viral hepatitis among all included patients. | During the inclusion assessment at day 1 (Visit 0) and at 1 month (visit 1) |
| Description of socio-demographic characteristics of participants | Description of the socio-demographic characteristics of people benefiting from an assessment of liver fibrosis by transient elastometry (Fibroscan®) as part of the study. Socio-demographic characteristics will be collected by a patient questionnaire (age, education, profession, income, health insurance, marital status, housing, living conditions) realised face to face with the doctor. | During the inclusion assessment at day 1 (Visit 0) |
| 34537988 | Background | Gines P, Castera L, Lammert F, Graupera I, Serra-Burriel M, Allen AM, Wong VW, Hartmann P, Thiele M, Caballeria L, de Knegt RJ, Grgurevic I, Augustin S, Tsochatzis EA, Schattenberg JM, Guha IN, Martini A, Morillas RM, Garcia-Retortillo M, de Koning HJ, Fabrellas N, Pich J, Ma AT, Diaz MA, Roulot D, Newsome PN, Manns M, Kamath PS, Krag A; LiverScreen Consortium Investigators. Population screening for liver fibrosis: Toward early diagnosis and intervention for chronic liver diseases. Hepatology. 2022 Jan;75(1):219-228. doi: 10.1002/hep.32163. Epub 2021 Dec 10. |
| 15082596 | Background | Dam-Larsen S, Franzmann M, Andersen IB, Christoffersen P, Jensen LB, Sorensen TI, Becker U, Bendtsen F. Long term prognosis of fatty liver: risk of chronic liver disease and death. Gut. 2004 May;53(5):750-5. doi: 10.1136/gut.2003.019984. |
| 7475591 | Background | Teli MR, Day CP, Burt AD, Bennett MK, James OF. Determinants of progression to cirrhosis or fibrosis in pure alcoholic fatty liver. Lancet. 1995 Oct 14;346(8981):987-90. doi: 10.1016/s0140-6736(95)91685-7. |
| 26256938 | Background | 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: 10.1016/j.drugpo.2015.07.002. Epub 2015 Jul 16. |
| Background | Mwamba-Kalambayi P, Etienne A, Chirpaz E, Gelu-Simeon M, Cuissard L, Deloumeaux J, et al. Étude comparative de la fréquence des hépatites B et C chez les personnes nouvellement diagnostiquées pour carcinome hépatocellulaire en France métropolitaine et dans les départements et régions d'outre-mer, 2015-2019. Bull Epidémiol Hebd. 2022;(3-4): 85-94. |
| Background | Oberti F, Cailliez E, Hubert I et al. Dépistage de la fibrose hépatique en populations générale et de médecine générale (étude DEFIH). Gastroenterol Clin Biol 2006;30:A7. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |