Philadelphia, Pennsylvania 19104

  • Hypertension, Portal

Purpose:

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.


Criteria:

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 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


NCT ID:

NCT04720456


Primary Contact:

Principal Investigator
Flemming Forsberg, PhD
Thomas Jefferson University

Morgan L Gabbert, MA
Phone: 267-426-0820
Email: gabbertm@email.chop.edu


Backup Contact:

N/A


Location Contact:

Philadelphia, Pennsylvania 19104
United States

Morgan L Gabbert, MA
Phone: 267-426-0820
Email: gabbertm@email.chop.edu

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 23, 2021

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