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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liver elastography (2D-SWE) | Diagnostic Test | All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Comparison of radiological imaging tests between each other II |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary diagnosis of chronic viral liver disease who are referred treating gastroenterologist/infectologist for liver biopsy prior to treatment.
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| Name | Affiliation | Role |
|---|---|---|
| Algirdas E Tamosiunas, MD, PhD | Vilnius University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vilnius University | Vilnius | 211950810 | Lithuania |
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| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
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| Liver scintigraphy with 99mTc-mebrofenin | Diagnostic Test | All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy. |
|
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 |
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |