Clinical Trial

SHAPE of Portal Hypertension in Children

Recruiting Phase 2
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Record status
This record was last updated February 11, 2025 (before its estimated July 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-01-19; most recent amendment 2025-02-07.
Status change: Not Yet Recruiting → Recruiting 2022-01-20
Trial Details
NCT Number NCT04720456
Lead Sponsor Thomas Jefferson University
Collaborators: Children's Hospital of Philadelphia, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions Hypertension, Portal
Enrollment 120 participants
Start Date 2021-11-03
Primary Completion 2025-07 (estimated)
Study Completion 2025-08 (estimated)
Updated on ClinicalTrials.gov 2025-02-11