CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 34 enrolled
Drug / intervention
Transient elastography (TE) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01905254
NCT01905254N/ACompleted

Prospective Comparison of Transient Elastography and Mini-laparoscopic Guided Liver Biopsy in Autoimmune Hepatitis

Universitätsklinikum Hamburg-Eppendorf·interventional·Posted Jul 23, 2013·Updated May 6, 2015

In Brief

A clinical study evaluating Transient elastography (TE) and Liver biopsy for Liver Cirrhosis. Completed, enrolled 34 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLiver Cirrhosis
CountriesGermany
Collaborators--

Timeline

N/ACompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 23, 2013
Enrollment StartAug 1, 2007
Primary CompletionAug 1, 2010
Study CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 12.9 years ago

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.

Liver biopsyother

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