Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children
Thomas Jefferson University
Summary
Early diagnosis of portal hypertension is difficult as symptoms rarely manifest until the later stages of liver disease. Both cirrhotic and non-cirrhotic portal hypertension can result in life-threatening complications, the most frequent of which is bleeding from esophageal varices. In children, variceal bleeds are associated with mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of children with cirrhosis. Despite the high incidence of portal hypertension in children with liver disease, a noninvasive modality to monitor disease progression and risk of complications is currently lacking. Hence, this trial will investigate the safety and efficacy of subharmonic aided pressure estimation (SHAPE) as a noninvasive ultrasound technique for diagnosing portal hypertension in children.
Eligibility
- Age range
- 6–21 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients with a diagnosis of chronic liver disease without portal hypertension. * Patients with a diagnosis of chronic liver disease with portal hypertension. Exclusion Criteria: * Subjects who are pregnant. * Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products. * Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded. * History of allergic reaction to Lumason®, sulfur hexafluoride, sulfur hexafluoride lipid microsphere compon…
Interventions
- DrugSHAPE measurement using the ultrasound contrast agent Sonazoid (perfluorobutane microbubbles)
The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.
- DrugSHAPE measurement using the ultrasound contrast agent Lumason (sulfur hexafluoride lipid-type A microspheres)
The ultrasound contrast agent will be infused thorough an IV line and SHAPE ultrasound imaging and data acquisition will be performed with a Logiq E10 (GE Medical Systems, Waukesha, WI) ultrasound scanner.
Location
- The Children's Hospital of PhiladelphiaPhiladelphia, Pennsylvania