# Noninvasive Portal Pressure Measurements in Children

> **NIH NIH R01** · THOMAS JEFFERSON UNIVERSITY · 2022 · $624,631

## Abstract

A common complication of pediatric portal hypertension is gastroesophageal varices and variceal bleeds are
associated mortality rates of 1-3 %, while life-threatening complications have been reported in up to 20 % of
children with cirrhosis. Currently, pediatricians evaluate portal hypertension through indirect means, since the
clinical standard in adults (the hepatic venous pressure gradient – HVPG) is not used routinely in children. There
are many causes of liver disease in children (biliary atresia, congenital hepatic fibrosis, alpha-1-antitrypsin
deficiency, autoimmune liver disease, etc.), each with a unique disease course, which also makes adult
guidelines difficult to apply to children. Consequently, the development of an accurate and noninvasive
technique for measurement of portal venous pressure would represent a major advance in the diagnosis and
management of portal hypertension in children. Our group developed the fundamental concept of SHAPE and
produced the first ever in vivo SHAPE estimates (in canines). We also conducted a first-in-humans, pilot study
of this technique's ability to estimate portal pressures in 45 adult patients supported by an NIDDK Challenge
Grant (RC1 DK087365), which showed significantly higher SHAPE gradients between the portal and hepatic
veins in subjects with portal hypertension (HVPG > 10 mmHg) than in those with lower HVPGs (1.37 ± 0.59 vs.
-1.68 ± 0.27, p < 0.001). Recently, we have expanded the concept of using SHAPE for portal pressure estimation
in an ongoing larger multi-center clinical trial (supported by R01 DK398526). Preliminary results in 120 subjects
obtained with the contrast agent Sonazoid (GE Healthcare, Oslo, Norway) have been very encouraging with an
accuracy for diagnosing portal hypertension of 94.2% and combined with the recent FDA approval of an
ultrasound contrast agent (Lumason; Bracco, Milan, Italy) for pediatric applications have encouraged us to bring
together researchers from Thomas Jefferson University (TJU) as well as the Children's Hospital of Philadelphia
(CHOP) with a premier manufacturer of ultrasound scanners (GE Healthcare) in order to produce a device for
noninvasive and accurate assessment of portal hypertension in children. First the SHAPE algorithm will be
implemented on a state-of-the-art ultrasound scanner (Logiq E9 with a C2-9 pediatric probe; GE Healthcare,
Milwaukee, WI) for real time pressure measurements in children. Following in vitro studies comparing Sonazoid
directly to Lumason, we will conduct an initial clinical trial at CHOP of in vivo SHAPE in children with a clinical
diagnosis of portal hypertension compared to a matched group of children with chronic liver disease but without
portal hypertension. We will also monitor disease progression or treatment response in children identified with
portal hypertension by comparing SHAPE results to clinical outcomes. Hence, this study aims to further develop
a novel and innovative ultrasound based technology (i.e.,...

## Key facts

- **NIH application ID:** 10242755
- **Project number:** 5R01DK118964-04
- **Recipient organization:** THOMAS JEFFERSON UNIVERSITY
- **Principal Investigator:** Sudha Anupindi
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $624,631
- **Award type:** 5
- **Project period:** 2018-09-01 → 2025-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10242755

## Citation

> US National Institutes of Health, RePORTER application 10242755, Noninvasive Portal Pressure Measurements in Children (5R01DK118964-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10242755. Licensed CC0.

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