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RecruitingCirrhosis, LiverGastroesophageal VaricesFontan Procedure

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

Eligible age

18+ yrs

Accepts

All genders

Locations

1 state

Healthy volunteers

Yes

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About this study

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.

Sponsor: University of Wisconsin, Madison

You may qualify if…

  • 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
  • Adults (\>18 years) with known cirrhosis
  • Adults (\>18 years) with Fontan repair and diagnosed FALD

You may not qualify if…

  • 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.
  • Contraindications to MRI
  • Recent treatment (\< 1 year) for varices
  • Known occlusive thrombus in portal vein; splenic vein, or superior mesenteric vein

Where it's recruiting

Wisconsin

Madison

Source: ClinicalTrials.gov · NCT04867954 · last updated 2026-04-09