Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 SWEâ„¢ 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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT-2D-SWE measurement | Procedure | measurement of liver and spleen stiffness by ultrasound real-time 2D shear wave elastography (SWEâ„¢) | ||
| HVPG measurement | Procedure | assessment of portal hypertension assessed by hepatic venous pressure gradient measurement |
| Measure | Description | Time Frame |
|---|---|---|
| liver and spleen stiffness | liver and spleen stiffness expressed in kPa, measured by real-time 2D shear wave elastography (SWE™) on Aixplorer® ultrasound machine from SuperSonic Imagine, Aix-en-Provence, France | at the time of enrollment |
| HVPG | severity of portal hypertension assessed by hepatic venous pressure gradient (HVPG) measurements | within one week of enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| development of hepatic decompensation | hepatic decompensation defined as: onset of icterus, onset of ascites diagnosed by transabdominal ultrasonud or CT scan, onset of portal encephalophaty diagnosed clinically, episode of variceal bleeding confirmed endoscopically | during follow-up period of 5 years |
| Hepatocellular carcinoma (HCC) development |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
outpatients and inpatients in a tertiary care hospital 1) with suspicion of having compensated advanced chronic liver disease (cACLD) as assessed by transabdominal ultrasound, laboratory findings, FIB-4 and/or APRI score, and/or LS measurements by TE; 2) patients with chronic liver disease in whom any extrahepatic surgical procedure is planned and in whom it was not possible to exclude cACLD and/or portal hypertension based on non-invasive procedures only; 3) patients with HCC or other liver tumors on the ground of presumed liver cirrhosis who are under consideration for surgical resection, in whom HVPG is performed in order to reliably exclude clinically significant portal hypertension
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ivica Grgurevic, MD, PhD | Contact | ivica.grgurevic@zg.htnet.hr | ||
| Tomislav Bokun, MD | Contact | tbokun@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Ivica Grgurevic, MD, PhD | University Hospital Dubrava | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Dubrava | Recruiting | Zagreb | 10040 | Croatia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23058320 | Background | Berzigotti A, Seijo S, Arena U, Abraldes JG, Vizzutti F, Garcia-Pagan JC, Pinzani M, Bosch J. Elastography, spleen size, and platelet count identify portal hypertension in patients with compensated cirrhosis. Gastroenterology. 2013 Jan;144(1):102-111.e1. doi: 10.1053/j.gastro.2012.10.001. Epub 2012 Oct 8. | |
| 24211744 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
conformed by contrast MDCT and/or MRI and/or tumor biopsy |
| during follow-up period of 5 years |
| mortality | during follow-up period of 5 years |
| Augustin S, Millan L, Gonzalez A, Martell M, Gelabert A, Segarra A, Serres X, Esteban R, Genesca J. Detection of early portal hypertension with routine data and liver stiffness in patients with asymptomatic liver disease: a prospective study. J Hepatol. 2014 Mar;60(3):561-9. doi: 10.1016/j.jhep.2013.10.027. Epub 2013 Nov 6. |
| 21376047 | Background | Vergniol J, Foucher J, Terrebonne E, Bernard PH, le Bail B, Merrouche W, Couzigou P, de Ledinghen V. Noninvasive tests for fibrosis and liver stiffness predict 5-year outcomes of patients with chronic hepatitis C. Gastroenterology. 2011 Jun;140(7):1970-9, 1979.e1-3. doi: 10.1053/j.gastro.2011.02.058. Epub 2011 Mar 2. |
| 22643348 | Background | Colecchia A, Montrone L, Scaioli E, Bacchi-Reggiani ML, Colli A, Casazza G, Schiumerini R, Turco L, Di Biase AR, Mazzella G, Marzi L, Arena U, Pinzani M, Festi D. Measurement of spleen stiffness to evaluate portal hypertension and the presence of esophageal varices in patients with HCV-related cirrhosis. Gastroenterology. 2012 Sep;143(3):646-654. doi: 10.1053/j.gastro.2012.05.035. Epub 2012 May 27. |
| 24607624 | Background | Colecchia A, Colli A, Casazza G, Mandolesi D, Schiumerini R, Reggiani LB, Marasco G, Taddia M, Lisotti A, Mazzella G, Di Biase AR, Golfieri R, Pinzani M, Festi D. Spleen stiffness measurement can predict clinical complications in compensated HCV-related cirrhosis: a prospective study. J Hepatol. 2014 Jun;60(6):1158-64. doi: 10.1016/j.jhep.2014.02.024. Epub 2014 Mar 6. |
| 23729981 | Background | Behrens G, Ferral H. Transjugular liver biopsy. Semin Intervent Radiol. 2012 Jun;29(2):111-7. doi: 10.1055/s-0032-1312572. |
| 24007769 | Background | Dohan A, Guerrache Y, Boudiaf M, Gavini JP, Kaci R, Soyer P. Transjugular liver biopsy: indications, technique and results. Diagn Interv Imaging. 2014 Jan;95(1):11-5. doi: 10.1016/j.diii.2013.08.009. Epub 2013 Sep 3. |