Liver Fibrosis in Sickle Cell Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Anemia, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology, Hematology |
| Healthy: | No |
| Age Range: | 10 - 65 |
| Updated: | 2/8/2019 |
| Start Date: | July 2012 |
| End Date: | June 30, 2019 |
| Contact: | Ofelia Alvarez, MD |
| Email: | oalvarez2@med.miami.edu |
| Phone: | 305.243.0846 |
Assessment of Liver Fibrosis in Patients With 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. A comparison with the results of FibroScan to
patients with Sickle cell without known liver disease, who have never been on chronic
transfusions and with normal liver function profiles will also be made.The primary hypothesis
is that the results of FibroScan will correlate with the results of Ferriscan and liver
biopsy.
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. A comparison with the results of FibroScan to
patients with Sickle cell without known liver disease, who have never been on chronic
transfusions and with normal liver function profiles will also be made.The primary hypothesis
is that the results of FibroScan will correlate with the results of Ferriscan and liver
biopsy.
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 ultrasound 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.
This study will also compare the results of FibroScan to patients with Sickle cell without
any known liver disease, who have never been on chronic transfusions (defined as no more than
4 transfusions in lifetime) and who have normal liver function profiles.
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 ultrasound 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.
This study will also compare the results of FibroScan to patients with Sickle cell without
any known liver disease, who have never been on chronic transfusions (defined as no more than
4 transfusions in lifetime) and who have normal liver function profiles.
Inclusion Criteria:
- pediatric patients age 10 years and older with sickle cell disease
- meeting other criteria:
1. history of chronic transfusion and iron overload and/or
2. known liver disease related to sickle cell or iron overload
- signed consent and assent (as applicable)
Exclusion Criteria:
- children younger than 10 years
- Pregnant females
- Prisoners
- Other causes of liver disease, unrelated to sickle cell or iron overload
Inclusion criteria for controls:
- Patients 10 years and older with sickle cell disease without history of chronic
transfusions (less than 4 transfusions in a lifetime)
- and without obvious liver disease.
We found this trial at
1
site
University of Miami A private research university with more than 15,000 students from around the...
Click here to add this to my saved trials
