Non-Invasive Characterization of Focal Liver Lesions in Liver Cirrhosis

NCT ID: NCT03746210

Last Updated: 2022-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-01

Study Completion Date

2027-12-31

Brief Summary

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This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Detailed Description

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This study aims to analyze non-invasive characterization focal liver lesions in patients with liver cirrhosis. The diagnostic accuracy and predictive value of non-invasive methods is studied.

Upon diagnosis multiparametric ultrasound imaging of the lesions as well as sarcopenia parameters are performed for characterization of the lesions. For primary endpoint the results are then analyzed with regard to diagnostic accuracy compared to gold standard (CT, MRI or histology). For secondary endpoint, predictive value of the non-invasive diagnostics are analyzed with regards to mortality and response to treatment.

All work up, treatment and follow up are applied in standard of care fashion.

Conditions

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Liver Cirrhoses

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Standard diagnostic procedures

B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* all patients with focal liver lesions and liver cirrhosis

Exclusion Criteria

* no consent
* under 18 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Michael Praktiknjo

Principal Investigator / Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital Bonn

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Michael Praktiknjo, MD

Role: CONTACT

+4922828715770

Johannes Chang, MD

Role: CONTACT

+4922828715770

Facility Contacts

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Michael Praktiknjo, MD

Role: primary

+49228 28715770

Johannes Chang, MD

Role: backup

+49228 28715770

Other Identifiers

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NICETIES

Identifier Type: -

Identifier Source: org_study_id

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