- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04459897
Lyon Granulomatous Hepatitis Study (LGH)
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.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Pascal Sève
- Phone Number: +33 4 26 73 26 36
- Email: pascal.seve@chu-lyon.fr
Study Locations
-
-
-
Lyon, France, 69004
- Recruiting
- : Hôpital de la Croix Rousse / GHN / service de médecine interne
-
Contact:
- Pascal Sève
- Phone Number: +33 4 26 73 26 36
- Email: pascal.seve@chu-lyon.fr
-
Lyon, France, 69008
- Recruiting
- Hôpital Edouard Herriot / service de médecine interne
-
Contact:
- Arnaud Hot
- Phone Number: +33 4 72 11 75 65
- Email: arnaud.hot@chu-lyon.fr
-
Pierre Bénite, France, 69495
- Recruiting
- Hôpital Lyon Sud / service de médecine interne
-
Contact:
- Isabelle First Name and Last Name : Isabelle Durieu
- Phone Number: +33 4 78 86 13 54
- Email: isabelle.durieu@chu-lyon.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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:
-
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
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).
|
: 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at inclusion visit
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- LGH_2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.