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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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 scheduled for EGD to assess for GEV.

Locations
United States
Wisconsin
University of Wisconsin, Madison
RECRUITING
Madison
Contact Information
Primary
Radiology Studies
radstudy@uwhealth.org
608-282-8349
Time Frame
Start Date: 2021-10-28
Estimated Completion Date: 2026-04
Participants
Target number of participants: 141
Treatments
Healthy volunteers
7 healthy participants will be recruited.
Patients with small, low-risk GEV
Patients with small, low-risk Gastroesophageal varices (GEV) will be recruited.
Patients with large, high-risk GEV
Patients with large, high-risk Gastroesophageal varices (GEV) will be recruited.
Patients scheduled for screening or surveillance esophagogastroduodenoscopy (EGD)
100 patients diagnosed with cirrhosis and scheduled for screening or surveillance esophagogastroduodenoscopy (EGD) procedure will be recruited. Participants will complete a single research visit, lasting approximately 2 hours, that will include the following procedures:~* Participants will fast for 12 hours prior to arriving.~* An IV will be placed and a blood sample collected (\~11 mL, if necessary).~* All participants will undergo research MRI lasting approximately 1.5 hours
Obese patients
20 obese patients will be recruited
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: University of Wisconsin, Madison

This content was sourced from clinicaltrials.gov