RecruitingPhase 2NCT04720456

SHAPE of Portal Hypertension in Children

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children


Sponsor

Thomas Jefferson University

Enrollment

120 participants

Start Date

Nov 3, 2021

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 6 YearsMax Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study uses a specialized ultrasound with a contrast agent to measure blood pressure in the portal vein (a major vein carrying blood to the liver) in children with liver disease. High pressure in this vein — called portal hypertension — is a serious complication of chronic liver disease. **You may be eligible if:** - You are a child with chronic liver disease, with or without portal hypertension **You may NOT be eligible if:** - You are pregnant - You have a known allergy to eggs or egg-based products (the contrast agent contains egg components) - You have had a prior liver transplant - You have cystic fibrosis, chronic lung disease, or significant heart disease - You have a clot or blockage in the portal vein - You have a syndrome involving missing or extra spleens (asplenia/polysplenia) with biliary atresia Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

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NCT04720456


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