Ignite Creation Date:
2024-05-06 @ 6:47 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05789641
Status:
RECRUITING
Last Update Posted:
2023-08-03
First Post:
2023-03-16
Brief Title:
Multimodal Ultrasound and Portal Hypertension
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Role of Dynamic Contrast-enhanced Ultrasound D-CEUS and 2D Elastography in the Evaluation of Portal Hypertension and Risk of Oesophageal Variceal Bleeding in Patients With Liver Cirrhosis
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 oesophagealgastric 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
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
Detailed Description:
Background About 80-90 of cirrhotic patients shows portal hypertension signs including ascites splenomegaly oesophageal andor 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 oesophagealgastric 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 150000m3 Baveno VI criteria or 100000mm3 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 andor 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 andor 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 α005 and a power of 90 a sample size of N73 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
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 andor 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 andor 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 α005 and a power of 90 a sample size of N73 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None