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

Completed

• Conditions: Liver Fibroses; Liver Cirrhosis
• Interventions: Diagnostic Test: Liver elastography (2D-SWE); Diagnostic Test: Liver scintigraphy with 99mTc-mebrofenin

• Registration Number: NCT05008263
• Lead Sponsor: Vilnius University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2021-06
• Study First Submitted: 2021-06-23
• Study First Submitted QC: 2021-08-16
• Last Update Submitted: 2021-08-16
• Study First Posted: 2021-08-17
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with viral chronic liver disease at primary diagnosis	Liver elastography (2D-SWE)	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.
Patients with viral chronic liver disease at primary diagnosis	Liver scintigraphy with 99mTc-mebrofenin	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.

Primary Outcome Measures

Name	Time	Method
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III	Baseline only	Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver excretion (30 min./peak ratio) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Ultrasound elastography comparison to histological examination of liver biopsy specimen	Baseline only	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I	Baseline only	Dynamic liver scintigraphy with 99mTc-mebrofenin parameter liver clearance (%/min/m2) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.
Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II	Baseline only	Dynamic liver scintigraphy with 99mTc-mebrofenin parameter uptake time (min.) is compared to histological examination of liver biopsy specimen at a single time point before initiating antiviral treatment.

Secondary Outcome Measures

Name	Time	Method
Comparison of radiological imaging tests between each other III	Baseline only	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer uptake time measured by dynamic liver scintigraphy with 99mTc-mebrofenin.
Comparison of radiological imaging tests between each other I	Baseline only	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to liver clearance measured by dynamic liver scintigraphy with 99mTc-mebrofenin.
Comparison of radiological imaging tests between each other II	Baseline only	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer excretion measured by dynamic liver scintigraphy with 99mTc-mebrofenin.

Trial Locations

Locations (1)

Vilnius University; 🇱🇹 Vilnius, Lithuania