Trial Outcomes & Findings for Transient Elastography in Autoimmune Hepatitis (NCT NCT01905254)

NCT ID: NCT01905254

Last Updated: 2015-05-06

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

34 participants

Primary outcome timeframe

Transient Elastography compared to liver histology

Results posted on

2015-05-06

Participant Flow

Thirty-nine patients with AIH were eligible during the study period. Five patients were excluded: 4 patients due to ineffective or incomplete (\<60% success rate) liver stiffness measurement, and 1 patient with a severe acute flare of AIH with markedly elevated liver enzymes."

Participant milestones

Participant milestones
Measure	Transient Elastography and Liver Biopsy Transient elastography was performed by two experienced investigators using a FibroScan (EchoSens, Paris, France), the median value of liver stiffness measurements was recorded in kilopascals (kPa). Liver biopsy was carried out within 3 months of TE. Liver biopsies from the right and left lobe were obtained under laparoscopic control using the Tru-cut 16 GAUGE needle (Bard monopty; Bard biopsy systems, Tempe, USA). Data analysis was performed on the remaining 34 patients (female: 28 (82%); male: 6 (18 %). Indications for liver biopsy and Transient elastography were: 19 patients for follow-up of AIH while receiving immunosuppression and 15 patients for staging and grading of AIH before starting with an immunosuppressive therapy in.
Overall Study STARTED	34
Overall Study COMPLETED	34
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transient Elastography in Autoimmune Hepatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm Study n=34 Participants Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis.
Age, Continuous	53 years n=5 Participants
Sex: Female, Male Female	28 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Germany	34 participants n=5 Participants

PRIMARY outcome

Timeframe: Transient Elastography compared to liver histology

Population: Sensitivity, specifity; Positive and negative predictive value of TE for diagnosis of cirrhosis was analyzed.

Outcome measures

Outcome measures
Measure	Transient Elastography in Autoimmune Hepatitis n=34 Participants Liver stiffness (kPa) was correlated to histologic staging of liver cirrhosis
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis Specifity of TE for diagnosis cirrhosis	1.00 Probability
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis Sensitivity of TE for diagnosis cirrhosis	0.83 Probability
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis Positive predictive value of TE for cirrhosis	1.00 Probability
Sensitivity and Specifity of Transient Elastography in Detection of Liver Cirrhosis Negative predictive value of TE for cirrhosis	0.97 Probability

Adverse Events

TE in Autoimmune Hepatitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TE in Autoimmune Hepatitis n=34 participants at risk Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis. There were no adverse events.
Gastrointestinal disorders Pain after liver biopsy	0.00% 0/34
Hepatobiliary disorders Bleeding after liver biopsy	0.00% 0/34

Other adverse events

Other adverse events
Measure	TE in Autoimmune Hepatitis n=34 participants at risk Alle patients received a liver biopsy and Transient elastopgrapy for follow-up of Autoimmune Hepatitis or staging and grading of Autoimmune hepatitis. There were no adverse events.
Cardiac disorders Hypotension	0.00% 0/34

Additional Information

PD Dr. Ulrike Denzer

Universitiy Clinic Hamburg eppendorf

Phone: 040741055380

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place