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Lyon Granulomatous Hepatitis Study (LGH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04459897
Recruitment Status : Recruiting
First Posted : July 7, 2020
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

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.


Condition or disease Intervention/treatment
Patient Diagnosed or Treated for Granulomatous Hepatitis Followed in the Internal Medicine (and or) Hepato-gastroenterology Departments Other: Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.

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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Lyon Granulomatous Hepatitis Study
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : January 1, 2023
Estimated Study Completion Date : January 1, 2023

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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).
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




Primary Outcome Measures :
  1. Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach. [ Time Frame: at inclusion visit ]
    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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patient diagnosed or treated for granulomatous hepatitis followed in the internal medicine and / or Hepato-gastroenterology departments
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:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459897


Contacts
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Contact: Pascal Sève 4 26 73 26 36 ext +33 pascal.seve@chu-lyon.fr

Locations
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France
: Hôpital de la Croix Rousse / GHN / service de médecine interne Recruiting
Lyon, France, 69004
Contact: Pascal Sève    4 26 73 26 36 ext +33    pascal.seve@chu-lyon.fr   
Hôpital Edouard Herriot / service de médecine interne Recruiting
Lyon, France, 69008
Contact: Arnaud Hot    4 72 11 75 65 ext +33    arnaud.hot@chu-lyon.fr   
Hôpital Lyon Sud / service de médecine interne Recruiting
Pierre Bénite, France, 69495
Contact: Isabelle First Name and Last Name : Isabelle Durieu    4 78 86 13 54 ext +33    isabelle.durieu@chu-lyon.fr   
Sponsors and Collaborators
Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04459897    
Other Study ID Numbers: LGH_2020
First Posted: July 7, 2020    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Hepatitis Granulomatous
liver sarcoidosis
prognosis
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections