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Metadata

Name
Correlation of Liver and Spleen Stiffness by RT-2D-SWE and Severity of Portal Hypertension by HVPG
Repository
ClinicalTrials.gov
Identifier
clinicaltrials:NCT02653846
Description
Portal hypertension (PH) results from the increase of portal flow resistance in fibrotic
tissue of the liver in patients with chronic liver diseases, leading to complications such as
varices formation and variceal bleeding, ascites formation, spleenomegaly and
hypersplenismus, systemic haemodynamic disorders and porto-systemic shunts formation. Early
detection of PH in patients with chronic liver diseases is clinically important as it should
change patient management in order to prevent the formation/onset or recurrence of PH
complications. Hepatic venous pressure gradient (HVPG) measurement is the gold standard for
the assessment of the severity of PH. However, it is an invasive method with its risks, and
relatively costly. On the other hand transient elastography (TE) emerged as a non-invasive,
easy, safe and low cost method with the potential to assess the severity of PH, as liver
stiffness (LS) and spleen stiffens (SS) measured by TE showed very good correlation with
HVPG. Real-time 2D shear wave elastography (RT-2D-SWE) is an ultrasound elastography method
reliable for non-invasive assessment of fibrosis stage especially in chronic viral hepatitis,
but only preliminary data exist on the correlation of RT-2D-SWE measured LS/SS with and HVPG.
In this study we hypothesized that LS and SS measured by RT-2D-SWE correlate with HVPG
enabling RT-2D-SWE to be used for the assessment of severity of PH. The primary aim of this
study is to analyse correlation between LS and SS as assessed by RT-2D-SWE and TE with the
grade of portal hypertension as assessed by HVPG. The secondary aims are: 1) to analyse
clinical outcomes of these patients in order to determine if LS and/or SS as assessed by
RT-2D-SWE might predict adverse outcomes (liver decompensation, death or HCC development),
and 2) to compare clinical performance (AUC) of RT-2D-SWE and TE for the assessment of the PH
severity as well as for predicting clinical outcomes. Patients with suspicion of having
compensated advanced chronic liver disease (cACLD) as assesed by non-invasive methods
(transabdominal ultrasound, laboratory findings, FIB-4 and APRI score, and LS measurements by
TE), will be included. Since positive predictive value of non-invasive methods for cirrhosis
is generally not very reliable, these patients will be offered transjugular liver biopsy and
HVPG measurements as gold-standard methods to define the stage of liver disease and severity
of PH. These patients will undergo LS and SS measurements by RT-2D-SWE on Aixplorer
SuperSonic Imagine ultrasound system and HVPG measurements as well, with transjugular liver
biopsy performed during the same session. After SWE™ and HVPG measurement, 5-year follow-up
is planned, including standard surveillance: laboratory findings, transabdominal US every six
months and upper-GI endoscopy according to relevant guidelines, as well as treatment
according to relevant guidelines as indicated: beta blockers, endoscopic variceal ligation,
etiologic treatment and dietary measures. Appropriate statistical analysis will be undertaken
after the enrollment period, as well as after follow-up period.
Data or Study Types
clinical trial
Source Organization
Unknown
Access Conditions
available
Year
2015
Access Hyperlink
https://clinicaltrials.gov/ct2/show/NCT02653846

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