Lyon Granulomatous Hepatitis Study

NCT ID: NCT04459897

Last Updated: 2020-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-01

Study Completion Date

2023-01-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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diagnosed or treated for granulomatous hepatitis fol

The cohort is composed by patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments (Croix-Rousse Hospital, Edouard-Herriot Hospital, Lyon Sud Hospital Center).

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

Intervention Type OTHER

: 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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

\-
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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: Hôpital de la Croix Rousse / GHN / service de médecine interne

Lyon, , France

Site Status RECRUITING

Hôpital Edouard Herriot / service de médecine interne

Lyon, , France

Site Status RECRUITING

Hôpital Lyon Sud / service de médecine interne

Pierre-Bénite, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Pascal Sève

Role: CONTACT

4 26 73 26 36 ext. +33

Facility Contacts

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Pascal Sève

Role: primary

4 26 73 26 36 ext. +33

Arnaud Hot

Role: primary

4 72 11 75 65 ext. +33

Isabelle First Name and Last Name : Isabelle Durieu

Role: primary

4 78 86 13 54 ext. +33

Other Identifiers

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LGH_2020

Identifier Type: -

Identifier Source: org_study_id

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