Liver Fibrosis in Sickle Cell Disease
Patients with sickle cell disease many have a number of systemic complications, including liver problems. Some of these liver problems lead to liver fibrosis/cirrhosis, secondary to chronic blood transfusions. The purpose of this study is to investigate FibroScan readings in patients with sickle cell disease and iron overload secondary to blood transfusions, and to correlate the FibroScan results with Ferriscan.The primary hypothesis is that the results of FibroScan will correlate with the results of Ferriscan.
Sickle Cell Disease
Other: Liver transient elastography (Fibroscan)
Procedure: Liver biopsy
|Study Design:||Observational Model: Case-Only
Time Perspective: Cross-Sectional
|Official Title:||Assessment of Liver Fibrosis in Patients With Sickle Cell Disease|
- Liver transient elastography (FibroScan) of liver iron content and stiffness [ Time Frame: at imaging visit (3 minutes) ] [ Designated as safety issue: No ]Liver transient elastography (FibroScan) uses a probe consisting of an ultrasound transducer located at the end of a vibrating piston. The piston produces a vibration of low amplitude and frequency, which generate a shear wave that passes through the skin and liver tissue. The ultrasound then detects the propagation of the shear wave through the liver (at a depth of 25 - 65 mm below the skin surface) by measuring its velocity. The shear wave velocity is directly related to the tissue stiffness, with a higher velocity equating to higher tissue stiffness, corresponding to increasing severity of fibrosis.
- magnetic resonance imaging (MRI) measure of liver iron content and stiffness [ Time Frame: at imaging visit (about 30-60 minutes) ] [ Designated as safety issue: No ]
- liver function tests (ALT, AST, serum alkaline phosphate, GGTP, total bilirubin, direct bilirubin), complete blood count, platelets, reticulocyte count, serum ferritin to assess liver function and evaluate overall health [ Time Frame: at clinic visit blood draw (about 1 minute) ] [ Designated as safety issue: No ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||July 2017 (Final data collection date for primary outcome measure)|
Subjects with sickle cell disease
Patients will have blood tests done to evaluate liver function and general health, then have FibroScan and Ferriscan. A blinded (no access to laboratory parameters or available data) radiologist will interpret the Ferriscan. Liver biopsy will be also obtained (if not done within the previous year). Otherwise, the results of the recent liver biopsy.
Other: Liver transient elastography (Fibroscan)
Fibroscan will be performed as a measure of liver stiffness. The study will be obtained free of charge in this study.
Other Name: FibroScanOther: Ferriscan
Ferriscan will be done to assess the quantity of liver iron.Procedure: Liver biopsy
Liver biopsy will be done and the results will be compared to Fibroscan results.
Liver biopsy is the gold standard to examine the liver for iron deposits and histology. However, liver biopsy is invasive and involves a risk of bleeding and pain. Biopsy may also miss significant pathology if the small biopsy specimen is taken from an uninvolved part of the liver. Non-invasive techniques such as MRI are now used to evaluate the liver iron content. MRI can visualize the whole liver and measure liver iron content. MRI, however, will not detect liver scarring.
Liver transient elastography (FibroScan) is a non-invasive tool for assessing liver fibrosis or scarring by measuring liver stiffness (LSM). Compared with liver biopsy, FibroScan provides immediate results and is a painless, short (3 mins), simple procedure to perform. In some studies FibroScan reports have correlated well with liver biopsy results of fibrosis and cirrhosis, and with Ferriscan, ferritin and liver function tests.
This purpose of this study is to investigate the role of FibroScan in individuals with sickle cell anemia and iron overload or who have a diagnosis of liver disease, and to compare FibroScan readings with magnetic resonance imaging.
We will also compare the results of the Fibroscan with liver biopsy.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02007746
|Contact: Ofelia Alvarez, MDfirstname.lastname@example.org|
|United States, Florida|
|University of Miami||Recruiting|
|Miami, Florida, United States, 33136|
|Contact: Ofelia Alvarez, MD 305-243-0846 email@example.com|
|Sub-Investigator: Gaurav Saigal, MD|
|Sub-Investigator: Eugene Schiff, MD|
|Principal Investigator:||Ofelia Alvarez, MD||University of Miami - Director Sickle Cell Services Pediatric Hematology/Oncology|