SHAPE of Portal Hypertension in Children

Description

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.

Conditions

Hypertension, Portal

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Study Overview

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Study Details

Study overview

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.

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

SHAPE of Portal Hypertension in Children

Condition
Hypertension, Portal
Intervention / Treatment

-

Contacts and Locations

Philadelphia

The Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

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

Ages Eligible for Study

6 Years to 21 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Thomas Jefferson University,

Flemming Forsberg, PhD, PRINCIPAL_INVESTIGATOR, Thomas Jefferson University

Sudha A Anupindi, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital of Philadelphia

Study Record Dates

2024-08