Clinical Trials Logo
  1. Home
  2. Liver Cirrhosis
  3. NCT05008263
  4. Details
NCT05008263 Clinical Trial

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
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
See also
  Status Clinical Trial Phase
Recruiting NCT04533932 - Endosonographic Shear Wave Elastography for Liver Stiffness
Not yet recruiting NCT06031740 - A Comparison of Flexible Endoscopic Polidocanol Liquid and Foam Sclerotherapy in Cirrhotic Patients With Bleeding From Internal Hemorrhoids N/A
Not yet recruiting NCT06026267 - Efficacy of Conventional Dose Protocol vs Low Dose Protocol Albumin Use in Patients With Cirrhosis and High Risk Spontaneous Bacterial Peritonitis N/A
Not yet recruiting NCT06076330 - Efficacy of 5% Albumin v/s Plasmalyte in Combination With 20% Albumin for Fluid Resuscitation in Cirrhosis With Sepsis Induced Hypotension N/A
Enrolling by invitation NCT05055713 - A Randomized Controlled Study on the Treatment of Cirrhosis Combined With Hypersplenism N/A
Recruiting NCT04578301 - Predicting Acute-on-Chronic Liver Failure After Surgical Intervention in Chronic Liver Disease
Not yet recruiting NCT05120557 - Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH N/A
Not yet recruiting NCT05515861 - Evaluation of EUS in Preventing Rebleeding After Endoscopic Cyanoacrylate Injection for Gastric Varices N/A
Not yet recruiting NCT02710227 - Sleep Timing and Circadian Preferences in A Sample of Egyptian Patients With Hepatic Cirrhosis N/A
Not yet recruiting NCT03623360 - Functional MRI to Determine Severity of Cirrhosis
Completed NCT02917408 - Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
Active, not recruiting NCT02551250 - Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis
Recruiting NCT02239991 - Management of Perioperative Coagulopathy With Thromboelastometry (ROTEM) in Liver Transplant N/A
Enrolling by invitation NCT02256514 - Open Label Trial of Immunotherapy for Advanced Liver Cancer Phase 2
Terminated NCT02311985 - Comparison of Three Transfusion Strategies for Central Venous Catheterization in Cirrhotics: A Randomized Clinical Trial N/A
Terminated NCT01937130 - Pharmacokinetic and Pharmacodynamic Study of IDN-6556 in ACLF Phase 2
Recruiting NCT01618890 - Hepatic Venous Pressure Gradient-guided Versus Standard Beta-blocker Therapy in Primary Prevention of Variceal Bleeding Phase 3
Recruiting NCT01728688 - Safety and Efficacy of Human Autologous Peripheral Blood Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01728727 - Safety and Efficacy of Human Umbilical Cord Derived Mesenchymal Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2
Recruiting NCT01724697 - Safety and Efficacy of Human Bone Marrow Stem Cells for Treatment of HBV-related Liver Cirrhosis Phase 1/Phase 2