Transient Elastography in Autoimmune Hepatitis

NCT01905254 | Completed Results

• 1 other identifier: UKE IRB 2742
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Recent, research has focused on the evaluation of non-invasive methods for the assessment of liver fibrosis in patients with chronic liver disease. Among these methods, transient elastography is the most promising. The method has been investigated mainly in patients with viral hepatitis. Several studies have shown, that the optimal cut-off value of TE for detection of liver cirrhosis by transient elastography is highly dependent on the aetiology of the underlying liver disease. Only a few studies have evaluated the value of transient elastography for patients with autoimmune liver disease and here primarily patients with PBC and PSC. For patients with autoimmune hepatitis the data is limited. We prospectively investigated the diagnostic accuracy of TE in autoimmune hepatitis compared to liver histology with and without inclusion of the macroscopic appearance using mini-laparoscopy

Conditions

Liver Cirrhosis

Keywords

Transient elastography; mini-laparoscopy; liver biopsy; liver cirrhosis; autoimmune hepatitis

Outcome Measures

Primary Outcomes (1)

• Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis

  The aim of the current study was to assess the diagnostic accuracy (Sens., Spec.) of transient elastography for the determination of cirrhosis in patients with autoimmune hepatitis. TE was compared to the diagnosis of cirrhosis made on histology yielded by laparoscopic guided liver biopsy.

  Transient Elastography compared to liver histology

Study Arms (1)

Transient elastography and liver biopsy

OTHER

All patients with Autoimmune hepatitis (AIH) were investigated with Transient Elastography before liver biopsy

Device: Transient elastography (TE); Other: Liver biopsy

Interventions

Transient elastography (TE) DEVICE

TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.

Transient elastography and liver biopsy

Liver biopsy OTHER

Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography

Transient elastography and liver biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Confirmed diagnosis of AIH based on the diagnostic criteria revised by the International Autoimmune Hepatitis Group 2008 (20):
• liver related autoantibodies,
• hypergammaglobulinaemia,
• typical histological findings and
• absence of viral markers.

You may not qualify if:

• morbid obesity (BMI \> 40),
• ascites, ileus or subileus,
• peritonitis,
• pregnancy,
• extrahepatic cholestasis and
• a severe inflammatory flare of AIH.

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

Dept of Gastroenterology and Hepatology, University Medical Center Hamburg Eppendorf

Hamburg, Hamburg, 20246, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis; Hepatitis, Autoimmune

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hepatitis, Chronic; Hepatitis; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: PD Dr. Ulrike Denzer
• Organization: Universitiy Clinic Hamburg eppendorf

u.denzer@uke.de

040741055380

Study Officials

• Ulrike W Denzer, MD

  Universitätsklinikum Hamburg-Eppendorf

  PRINCIPAL INVESTIGATOR

• Ansgar W Lohse, MD

  Universitätsklinikum Hamburg-Eppendorf

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 23, 2013
• Study Start: August 1, 2007
• Primary Completion: August 1, 2010
• Study Completion: January 1, 2013
• Last Updated: May 6, 2015
• Results First Posted: May 6, 2015

Record last verified: 2015-05

Locations

DE (1)