Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments Clinical Trial
— LGHOfficial title:
Lyon Granulomatous Hepatitis Study
| NCT number | NCT04459897 |
| Other study ID # | LGH_2020 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | January 1, 2019 |
| Est. completion date | January 1, 2023 |
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.
| Status | Recruiting |
| Enrollment | 600 |
| Est. completion date | January 1, 2023 |
| Est. primary completion date | January 1, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Diagnosis of granulomatous hepatitis - Patient followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center) - Collection of non-opposition Exclusion Criteria: - |
| Country | Name | City | State |
|---|---|---|---|
| France | : Hôpital de la Croix Rousse / GHN / service de médecine interne | Lyon | |
| France | Hôpital Edouard Herriot / service de médecine interne | Lyon | |
| France | Hôpital Lyon Sud / service de médecine interne | Pierre Bénite |
| Lead Sponsor | Collaborator |
|---|---|
| Hospices Civils de Lyon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | at inclusion visit |