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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05008263
• Other study ID #: 158200-18/7-1053-552
• Status: Completed
• Start date: August 1, 2018
• Est. completion date: January 31, 2020

Study information

• Verified date: June 2021
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Liver Fibroses

Intervention

Diagnostic Test:
• Liver elastography (2D-SWE)
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
All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.

Locations

Country	Name	City	State
Lithuania	Vilnius University	Vilnius

Sponsors (1)

Lead Sponsor	Collaborator
Vilnius University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound elastography comparison to histological examination of liver biopsy specimen	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.	Baseline only
Primary	Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen I	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.	Baseline only
Primary	Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen II	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.	Baseline only
Primary	Dynamic liver scintigraphy with 99mTc-mebrofenin comparison to histological examination of liver biopsy specimen III	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.	Baseline only
Secondary	Comparison of radiological imaging tests between each other I	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to liver clearance measured by dynamic liver scintigraphy with 99mTc-mebrofenin.	Baseline only
Secondary	Comparison of radiological imaging tests between each other II	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer excretion measured by dynamic liver scintigraphy with 99mTc-mebrofenin.	Baseline only
Secondary	Comparison of radiological imaging tests between each other III	Liver stiffness measured by ultrasound elastography (2D-SWE) in kPa is compared to tracer uptake time measured by dynamic liver scintigraphy with 99mTc-mebrofenin.	Baseline only