Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis

NCT ID: NCT05008263

Last Updated: 2021-08-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-01
• Study Completion Date: 2020-01-31

Brief Summary

The study "Competitive Accuracy of Radiological Imaging Compared to Liver Biopsy in Patients With Liver Fibrosis" is designed to test the accuracy of non-interventional radiological imaging and compare its results with the "gold standard" liver biopsy. This is prospective non-randomized single patient group study.

Conditions

Liver Fibroses; Liver Cirrhosis

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with viral chronic liver disease at primary diagnosis

Patients with primary diagnosis of viral hepatitis B and hepatitis C who was referred for liver biopsy. All patients underwent liver shear wave elastography and dynamic liver scintigraphy evaluating liver physical and functional changes shortly prior to liver biopsy procedure.

Liver elastography (2D-SWE)

Intervention Type: DIAGNOSTIC_TEST

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Liver scintigraphy with 99mTc-mebrofenin

Intervention Type: DIAGNOSTIC_TEST

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Interventions

Liver elastography (2D-SWE)

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Intervention Type: DIAGNOSTIC_TEST

Liver scintigraphy with 99mTc-mebrofenin

All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• chronic liver disease
• signed informed consent
• liver biopsy indicated by treating gastroenterologist/infectologist

Exclusion Criteria

• non-corrected blood coagulation tests
• acute liver disease
• age below 18 years or above 80 years
• disagreement to participate in the study
• pregnancy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vilnius University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Algirdas E Tamosiunas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Locations

Vilnius University

Vilnius, , Lithuania

Countries

Lithuania

Other Identifiers

158200-18/7-1053-552

Identifier Type: -

Identifier Source: org_study_id