The SHUNT-V Study for Varices
Completed · Not applicable
Conditions studied: Chronic Liver Disease
In brief
The purpose of this study is to validate the Disease Severity Index (DSI) from the HepQuant SHUNT Liver Diagnostic Kit (Test) for likelihood of large esophageal varices.
Key facts
- Study ID
- NCT03583996
- Run by
- HepQuant, LLC
- People needed
- 306
- Starts
- 2019-01-23
- Expected to finish
- 2022-10-22
- Last updated by the study team
- 2025-04-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Ability to have a peripheral venous catheter for administration of the 13C cholate
- Ability to take the oral dose of d4-cholate
- Ability to hold morning doses of medications for the 90-minute duration of the HepQuant SHUNT Test
- Meets the protocol defined criteria for CLD in addition to having the diagnoses of CLD for >6 months
- Is scheduled, or in the process of being scheduled, for a standard of care EGD
You may not qualify if…
- Unable to give informed consent
- Unable to obtain venous access for administration of intravenous cholate
- Unable to absorb orally-administered cholate
- Known hypersensitivity to human serum albumin
- Known hypersensitivity to any of the components of the HepQuant SHUNT Liver Diagnostic Kit
- Acute hepatitis or Acute Liver Failure
- Acute drug-induced liver disease (DILI)
- Noncirrhotic causes for portal hypertension and varices
- Ongoing active alcoholic hepatitis
- Child-Pugh class C defined by Child-Pugh score 10 or higher
- Dialysis
- Active infection or febrile illness within the last month
- Documented history of esophageal or gastric variceal hemorrhage
- Documented history of treatment of esophageal varices
- Documented history of endoscopic findings of large esophageal varices
- Hepatocellular carcinoma beyond Milan or University of California, San Francisco (UCSF) criteria
- Thrombosis of main portal vein
- Liver transplant recipient
- Pregnancy
- Women who are breast-feeding
- Serious intercurrent medical or surgical illness, such as acute myocardial infarction, acute cerebral hemorrhage, sepsis, or other immediate life-threatening illness
Where it is running
- Arizona Liver Health — Chandler, Arizona, United States
- Southern CA Research Center — Coronado, California, United States
- California Liver Research Institute — Pasadena, California, United States
- Inland Empire Liver Foundation — Rialto, California, United States
- Peak Gastroenterlogy Associates — Colorado Springs, Colorado, United States
- Nature Coast Clinical Research — Inverness, Florida, United States
- Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
- Accel Research Sites — Orange City, Florida, United States
- Gastroenterology Associates of Pensacola — Pensacola, Florida, United States
- Gastroenterology Health Partners, PLLC — New Albany, Indiana, United States
- Tandem Clinical Research — Marrero, Louisiana, United States
- Digestive Disease Associates — Catonsville, Maryland, United States
- Mayo Clinic, Rochester — Rochester, Minnesota, United States
- St Louis University — St Louis, Missouri, United States
- Lucas Research (Diabetes & Endocrinology Consultants, PC) — Morehead City, North Carolina, United States
- PMG Research — Winston-Salem, North Carolina, United States
- Univ of Pennsylvania Hospital — Philadelphia, Pennsylvania, United States
- Ralph H Johnson Veterans Affairs Medical Center — Charleston, South Carolina, United States
- Methodist Dallas Liver Center — Dallas, Texas, United States
- Baylor, Scott & White — Dallas, Texas, United States
- Clinical Trials of Texas — San Antonio, Texas, United States
- Intermountain Healthcare — Murray, Utah, United States
- Bon Secours, Newport News — Newport News, Virginia, United States
- Bon Secours, Richmond — Richmond, Virginia, United States
- Gastroenterology Consultants of SW VA — Roanoke, Virginia, United States
Full record on ClinicalTrials.gov
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