SHAPE of Portal Hypertension in Children

Recruiting now · Phase 2

Conditions studied: Hypertension, Portal

In brief

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.

Key facts

Study ID

NCT04720456

Run by

Thomas Jefferson University

People needed

120

Starts

2021-11-03

Expected to finish

2025-08-01

Last updated by the study team

2025-02-11

Who can join

Age: 6 and older, up to 21. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with a diagnosis of chronic liver disease without portal hypertension.
• Patients with a diagnosis of chronic liver disease with portal hypertension.

You may not qualify if…

• 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 components, or other ingredients in Lumason (polyethylene glycol, distearoylphosphatidylcholine (DSPC), dipalmitoylphosphatidylglycerol sodium (DPPG-Na), palmitic acid)
• History of allergic reaction to Sonazoid
• Patients with biliary atresia with asplenia or polysplenia.
• Patients with prior liver transplant.
• Patients with cystic fibrosis.
• Patients with chronic lung disease.
• Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
• Adults not competent/impaired.
• Patients with significant heart disease or severe congenital heart disease

Where it is running

• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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