Population-based Study in Screening for Liver Fibrosis
- Conditions
- Liver Diseases
- Registration Number
- NCT03789825
- Lead Sponsor
- Judit Pich Martínez
- Brief Summary
Study to assess the prevalence of significant liver fibrosis in general population using Transient Elastography
- Detailed Description
This is a population-based study. Subjects will attend a primary care center where a physical examination, general blood test and transient elastography will be carried out. Only the group of patients with high-risk for liver fibrosis will be evaluated in a second visit at the University Hospital.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30000
- Age ≥ 40 years
- Able to give informed consent
- Previously known chronic liver disease (including cholestasis). Patients with already known liver steatosis but no diagnosis of liver fibrosis or cirrhosis can be included
- Subjects with mental incapacity, language barrier, insufficient social support or any other reason considered by the investigator precluding adequate understanding or cooperation in the study
- Subjects with a history of current malignancy including solid tumors and hematologic disorders
- Subjects with significant extrahepatic disease that may impair short-term prognosis (including congestive heart failure New York Heart Association Grade IV, COPD GOLD >3)
- Subjects with kidney disease (serum creatinine >3mg/dL or under renal replacement therapy)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method % of subjects with Liver stiffness measurement by Transient Elastography >=8 kPa at any visit Through study completion, an average of 24 months Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8 kPa at any visit, either with M or XL probe, in general population.
- Secondary Outcome Measures
Name Time Method % of subjects with Liver stiffness measurement by Transient Elastography >=8 kPa in the subgroup of patients with risk factors for chronic liver disease at visit 1 or 2 Through study completion, an average of 24 months Percentage of subjects with Liver stiffness measurement by Transient Elastography ≥ 8 kPa, either with M or XL probe, in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2.
Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores Through study completion, an average of 24 months Comparison of liver fibrosis diagnosis accuracy between Transient Elastography and fibrosis scores (including NAFLD fibrosis score, FIB-4, Forms index and APRI score) for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.
Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy Through study completion, an average of 24 months Comparison of liver fibrosis diagnosis accuracy between Transient Elastography, fibrosis scores and liver biopsy for the diagnosis of liver fibrosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available at visit 2.
% of subjects with CAP ≥250 dB/m Through study completion, an average of 24 months Percentage of subjects with CAP ≥250 dB/m, either with M or XL probe, in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and/or 2
Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores Through study completion, an average of 24 months Comparison of liver steatosis diagnosis accuracy between CAP and steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease at visit 1 and 2.
Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores and liver biopsy Through study completion, an average of 24 months Comparison of liver steatosis diagnosis accuracy between CAP, steatosis scores (including FLI, HIS, LAP, ION and NAFLD-LFS) and liver biopsy for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with liver biopsy available (at visit 2).
Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound Through study completion, an average of 24 months Comparison of liver steatosis diagnosis accuracy between CAP and abdominal ultrasound for the diagnosis of liver steatosis in general population and in the subgroup of patients with risk factors for chronic liver disease, in patients with abdominal ultrasound available at visit 2.
Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE Through study completion, an average of 24 months Comparison of values obtained with M and XL probes in the assessment of LSM and CAP via TE at visit 2.
Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population Through study completion, an average of 24 months Cost-effectiveness of a liver fibrosis screening program for liver fibrosis detection in general population and in the subgroup of patients with risk factors for chronic liver disease. Direct and indirect cost savings of early detection of liver fibrosis in subjects with risk factors for chronic liver diseases.
Percentage of failure rate for stiffness and steatosis measurements within TE examination Through study completion, an average of 24 months Percentage of failure rate for stiffness and steatosis measurements within TE examination at visit 1 and 2.
Percentage of patients with procedure related adverse events and serious adverse events Through study completion, an average of 24 months Percentage of patients with procedure related adverse events (adverse events related to TE and liver biopsy) and serious adverse events during all the duration of the study.
Percentage of patients with changes in lifestyle habits Through study completion, an average of 24 months Percentage of patients with changes in lifestyle habits
Trial Locations
- Locations (45)
Altstadtpraxis
🇩🇪Mainz, Germany
Praxis Mombach
🇩🇪Mainz, Germany
Medicina Di gruppo di montagnana
🇮🇹Padova, Italy
Vigonza Medica
🇮🇹Padova, Italy
F. D. Roosevelt Univ. Hospital
🇸🇰Banská Bystrica, Slovakia
CAP Besos
🇪🇸Barcelona, Spain
CAP Vila de Gracia
🇪🇸Barcelona, Spain
CAP Vila Olimpica
🇪🇸Barcelona, Spain
Hospital Gregorio Marañon
🇪🇸Madrid, Spain
CAP La Llantia
🇪🇸Mataró, Spain
James Wigg
🇬🇧London, United Kingdom
Mild May
🇬🇧London, United Kingdom
Oakleigh park
🇬🇧London, United Kingdom
Dubrava Hospital
🇭🇷Zagreb, Croatia
Poliklinika Croatia
🇭🇷Zagreb, Croatia
Odense University Hospital
🇩🇰Odense, Denmark
Centre de santé Municipal Etienne Gatineau-Sailliant de Genevilliers
🇫🇷Gennevilliers, France
Centre de Recherche Clinique - CRC
🇫🇷Paris, France
Hospital Avicenne
🇫🇷Paris, France
Hospital Beaujon
🇫🇷Paris, France
Homburg Hospital
🇩🇪Homburg, Germany
Mainz Hospital
🇩🇪Mainz, Germany
MVZ Dres.Schneider Kaiserslautern
🇩🇪Rodenbach, Germany
Medical Center Rotterdam
🇳🇱Rotterdam, Netherlands
Hospital Germans Trias i Pujol
🇪🇸Badalona, Barcelona, Spain
SEAT
🇪🇸Martorell, Barcelona, Spain
CAP II El Maresme
🇪🇸Mataró, Barcelona, Spain
CAP II Santa Coloma de Gramanet
🇪🇸Santa Coloma De Gramenet, Barcelona, Spain
CAP La Florida
🇪🇸Santa Perpètua De Mogoda, Barcelona, Spain
CAP Barceloneta
🇪🇸Barcelona, Spain
Hospital del Mar
🇪🇸Barcelona, Spain
CAP Bordeta-Magòria
🇪🇸Barcelona, Spain
CAP Río de Janeiro
🇪🇸Barcelona, Spain
Oak Lodge Medical Centre
🇬🇧Edgware, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
St Andrews Medical Practice
🇬🇧London, United Kingdom
Nottingham University Hospital
🇬🇧Nottingham, United Kingdom
King's Mill Hospital
🇬🇧Sutton In Ashfield, United Kingdom
CAP Ciutat Meridiana
🇪🇸Barcelona, Spain
CAP Sant Rafael
🇪🇸Barcelona, Spain
Hospital Universirati Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Clínic de Barcelona
🇪🇸Barcelona, Spain
CAP Adrià
🇪🇸Barcelona, Spain
CAP La Marina
🇪🇸Barcelona, Spain
CAP Numància
🇪🇸Barcelona, Spain