SHAPE of Portal Hypertension in Children

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Jefferson University
• Collaborators: Children's Hospital of Philadelphia; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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