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Lyon Granulomatous Hepatitis Study

NCT04459897 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2020-07-07

No results posted yet for this study

Summary

Granulomatous hepatitis are histopathologically defined by the presence of epithelioid and gigantocellular granulomas within the hepatic parenchyma. Hepatic granulomas are observed in 2 to 15% of liver biopsies. Causes of granulomatous hepatitis can be related to ethnic and environmental factors and in western countries granulomatous hepatitis are mostly related to sarcoidosis and autoimmune cholangitis. Infections (mycobacteria, coxiella burnetii, hepatitis C) and medications also provide granulomatous hepatitis.

Sarcoidosis is a systemic disease of unknown etiology, which in third of cases has a chronic course. Five percent of patients die of their disease, mainly because of respiratory distress. Hepatic involvement is most often asymptomatic or pauci-symptomatic (moderate cholestasis and conglomerates of granulomas visible on imaging). More rarely, it can cause portal hypertension and its complications and be life-threatening.

The aim of the Lyon Hepatitis Granulomatous (LHG) study is to better characterize granulomatous hepatitis and within these, severe hepatic sarcoidosis. This is a retrospective study conducted from January 2008 to December 2016 proposed to all patients with granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center). This study will cover 596 patients who had a liver biopsy showing granulomas.

The main objectives of the Lyon Hepatitis Granulomatous (LHG) study are to analyze i) the etiology of the disease and the contribution of molecular biology for infectious etiologies, ii) the contribution of nuclear imaging for sarcoidosis diagnosis versus conventional imaging, iii) treatment used and prognosis.

This study will permit a better characterization of granulomatous hepatitis, and liver sarcoidosis in terms of prognosis as well as therapeutic management.

Conditions

  • Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments

Interventions

OTHER

Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.

: Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous

Sponsors & Collaborators

  • Hospices Civils de Lyon

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2023-01-01
Completion
2023-01-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04459897 on ClinicalTrials.gov