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Completed NCT04867954

Development of 4D Flow MRI for Risk Stratification of Variceal Bleeding in Cirrhosis

Conditions: Cirrhosis, Liver, Gastroesophageal Varices, Fontan Procedure

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Enrollment: 84
Sponsor: University of Wisconsin, Madison

Location: University of Wisconsin, Madison Madison Wisconsin

Summary

The goal of this research is to validate novel non-invasive Magnetic resonance imaging (MRI) biomarkers to detect Gastroesophageal varices (GEV) in patients with cirrhosis, including fractional flow change in the portal vein and elevated azygos flow. End-stage liver disease (cirrhosis) is characterized by advanced fibrosis, liver failure, and portal hypertension. There are many causes of cirrhosis, including viral hepatitis, alcohol abuse, and perhaps most importantly, non-alcoholic fatty liver disease (NAFLD) and its aggressive subset, non-alcoholic steatohepatitis (NASH). 3 million new cases of end-stage liver disease (cirrhosis) are expected over the next decade. In cirrhosis, portosystemic collaterals that shunt blood away from the liver develop due to increased portal pressure. Gastroesophageal varices (GEV) are the most clinically relevant because they can cause fatal internal bleeding. GEV bleeding carries \~20% mortality at 6 weeks, and \~34% overall mortality. Identification of at-risk varices, prior to bleeding, is of paramount importance to initiate primary prophylaxis. To identify and treat at-risk patients, current guidelines recommend regular esophagogastroduodenoscopy (EGD) and variceal band ligation. Detection of high-risk GEV is key to initiating primary prophylaxis, which can reduce mortality by 50-70%. However, endoscopy is invasive and often unnecessary when no treatment is required. Therefore, the American Association for the Study of Liver Diseases has identified the development of "non-invasive markers that predict the presence of high-risk varices" as a major unmet need.

Eligibility Criteria

Inclusion Criteria for Aim 1: * Healthy volunteers: Adults (\>18 years) with no known liver pathology * Obese volunteers: Adults (\>18 years), no known liver pathology, body mass index (BMI) ≥ 35 * Patients: Adults (\>18 years) with known cirrhosis and known Gastroesophageal varices Exclusion Criteria for Aim 1: * contraindications to MRI * hypersensitivity reactions to both contrast agents * patients with recent treatment for varices with embolization, TIPS, or other endovascular treatment * patients with active GEV bleeding; known occlusive thrombus in portal vein, splenic vein, or superior mesenteric vein. * patients with large HCC with known PC involvement. Inclusion criteria for Aim 2-4: * Adults (\>18 years) with known cirrhosis Exclusion Criteria for Aim 2-4: * Contraindications to MRI * Recent treatment (\< 1 year) for varices * Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein * Large hepatocellular carcinoma (HCC) with known PV involvement * Hypersensitivity reactions to both contrast agents * Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The participant comes to the research visit with a driver. Inclusion Criteria for Aim 5: * Adults (\>18 years) with Fontan repair and diagnosed FALD Exclusion Criteria for Aim 5: * Contraindications to MRI * Recent treatment (\< 1 year) for varices * Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein * Large hepatocellular carcinoma (HCC) with known PV involvement * Hypersensitivity reactions to both contrast agents * Participants requiring conscious sedation for imaging are not eligible; participants requiring mild, oral anxiolytics for the clinical MRI scan will be allowed to participate as long as the following criteria are met: * The participant has their own prescription for the medication * The informed consent process is conducted prior to the self-administration of the medication. * The participant comes to the research visit with a driver.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04867954). StuddyBuddy aggregates publicly available trial information.