RECRUITING

SHAPE of Portal Hypertension in Children

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Noninvasive Subharmonic Aided Pressure Estimation of Portal Hypertension in Children

Quick Facts

Study Start:2021-11-03
Study Completion:2024-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04720456

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.

Ages Eligible for Study:6 Years to 21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patients with a diagnosis of chronic liver disease without portal hypertension.
  2. * Patients with a diagnosis of chronic liver disease with portal hypertension.
  1. * Subjects who are pregnant.
  2. * Patients with known or suspected hypersensitivity to egg phosphatidyl serine or with a history of anaphylactic allergy to eggs or egg products.
  3. * Subjects with allergy to egg products or other components of the ultrasound contrast agents will be excluded.
  4. * 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)
  5. * History of allergic reaction to Sonazoid
  6. * Patients with biliary atresia with asplenia or polysplenia.
  7. * Patients with prior liver transplant.
  8. * Patients with cystic fibrosis.
  9. * Patients with chronic lung disease.
  10. * Patients with portal vein thrombosis, cavernous transformation of the portal vein or absent portal vein.
  11. * Adults not competent/impaired.
  12. * Patients with significant heart disease or severe congenital heart disease

Contacts and Locations

Study Contact

Morgan L Gabbert, MA
CONTACT
267-426-0820
gabbertm@email.chop.edu

Principal Investigator

Flemming Forsberg, PhD
PRINCIPAL_INVESTIGATOR
Thomas Jefferson University
Sudha A Anupindi, MD
PRINCIPAL_INVESTIGATOR
Children's Hospital of Philadelphia

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-03
Study Completion Date2024-08

Study Record Updates

Study Start Date2021-11-03
Study Completion Date2024-08

Terms related to this study

Additional Relevant MeSH Terms

  • Hypertension, Portal