Clinical trial NCT04459897: Lyon Granulomatous Hepatitis Study
Official title: Lyon Granulomatous Hepatitis Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments
Keywords: Hepatitis Granulomatous
liver sarcoidosis
prognosis
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments

Brief 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.


Eligibility criteria: 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:

-

Primary outcomes:
measure: Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.
timeFrame: at inclusion visit
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: : Hôpital de la Croix Rousse / GHN / service de médecine interne
city: Lyon
country: France
facility: Hôpital Edouard Herriot / service de médecine interne
city: Pierre Bénite
country: France
facility: Hôpital Lyon Sud / service de médecine interne
Study officials:
References: