Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05789641 |
| Other study ID # |
2986 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 23, 2020 |
| Est. completion date |
December 2024 |
Study information
| Verified date |
August 2023 |
| Source |
Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Contact |
Maria Assunta Zocco |
| Phone |
00393470597805 |
| Email |
mariaassunta.zocco[@]policlinicogemelli.it |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
According to international guidelines, Hepatic Venous Pressure Gradient is the gold standard
technique for portal hypertension measurement, but it is invasive and poorly available.
Currently, surveillance of oesophageal/gastric varices is performed by upper gastrointestinal
endoscopy. More recently, non-invasive tools to estimate portal hypertension have been
developed and, among them, ultrasound elastography has been proposed as a technique to
stratify patient risk to have portal hypertension.
Aim of this study is to evaluate the relationship between ultrasound evaluation (D-CEUS +
elastography) and endoscopic parameters predictive of clinically significant portal
hypertension in patients with liver cirrhosis.
Description:
Background: About 80-90% of cirrhotic patients shows portal hypertension signs, including
ascites, splenomegaly, oesophageal and/or gastric varices, encephalopathy. According to
international guidelines, Hepatic Venous Pressure Gradient is the gold standard technique for
portal hypertension measurement, but it is invasive and poorly available. Currently,
surveillance of oesophageal/gastric varices is performed by upper gastrointestinal endoscopy.
More recently, non-invasive tools to estimate portal hypertension have been developed and,
among them, ultrasound elastography has been proposed as a technique to stratify patient risk
to have portal hypertension. More specifically, liver stiffness <20kPa together with platelet
count > 150.000/m3 (Baveno VI criteria) or > 100.000/mm3 (Expanded Baveno VI criteria) are
considered at low risk of portal hypertension. D-CEUS provides information about
microvascularization and it is widely used to characterize focal liver lesions, but recent
data show its role also in evaluating the degree of liver fibrosis and portal hypertension.
Primary objective: To evaluate the relationship between ultrasound evaluation (D-CEUS +
elastography) and endoscopic parameters predictive of clinically significant portal
hypertension in patients with liver cirrhosis.
Secondary objectives:
- To identify quantitative ultrasound parameters able to predict the presence of
clinically significant portal hypertension.
- To identify cut-off values of ultrasound parameters able to stratify the risk of
bleeding in patients with oesophageal varices
- To evaluate the relationship between the hemodynamic changes induced by endoscopic
and/or pharmacological therapy of oesophageal varices highlighted with ultrasound
(D-CEUS + elastography) and the hemodynamic changes highlighted by endoscopy.
Study design: Single-centre prospective observational study Methods: consecutive adult
patients with liver cirrhosis needing to undergo endoscopic evaluation of portal hypertension
will be enrolled in the Unit of Internal Medicine and Gastroenterology of the Policlinico
Agostino Gemelli. Cirrhotic patients of different aetiologies will be included. Exclusion
criteria will be previous recent endoscopic treatment of oesophageal varices (<6 months),
portal and/or splanchnic thrombosis, portal cavernomatosis, acute or chronic heart failure,
previous liver transplantation, presence of hepatocellular carcinoma or other hepatic
neoplasms, inadequate visualization of the liver parenchyma on B-mode ultrasound, known
allergy to ultrasound contrast medium, pregnancy and lactation. Assuming a disagreement rate
of 5% between ultrasonographic and endoscopic diagnosis and considering an α=0.05 and a power
of 90%, a sample size of N=73 patients is calculated. Patients will undergo ultrasound
(B-mode, shear-wave elatography and D-CEUS) and endoscopic evaluation (diagnostic
esophagogastroduodenoscopy plus endoscopic treatment of eosophageal or gastric varices, if
needed) as per clinical practice. After obtaining informed consent, personal, clinical and
laboratory data will be collected and analysed specifically for the study.
