A Study of Outpatients with Cirrhosis

Overview

About this study

The purpose of this study is to define the determinants of cirrhosis progression using clinical and specialized biomarkers over time in North America through a prospective outpatient registry.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Age > 18 years old.
  • Outpatient.
  • Able to give informed consent determined by MMSE ≥ 25 (those under this will be excluded and no LAR will be required).
  • In the opinion of the PI, able to be compliant with clinic follow-up over time.
  • Cirrhosis diagnosed by any one or more of the following:
    • Liver biopsy;
    • History of or current decompensation.
      • Ascites on diuretics, requiring TIPS or large volume paracentesis.
      • Prior overt HE.
      • Variceal bleeding.
      • Liver-lung syndromes (hepato-pulmonary syndrome, portopulmonary hypertension, hepatic hydrothorax).
      • Jaundice (serum bilirubin > 5mg/dl).
      • Hepato-renal syndrome or stage 2 AKI:
        • In a patient with chronic liver disease.
      • Fibroscan > 14.6 kPa.
      • Platelet count < 150,000 and AST/ALT ratio > 1.
  • Able and willing to provide samples.

Specific additional inclusion criteria for the three subgroups:

  • Patients without prior decompensation.
  • No history of overt HE on therapy, variceal bleeding being eradicated/on BB, HRS, ascites on current diuretics.
  • Control of underlying disease etiology should be at least 3 months prior.
    • SVR for HCV;
    • HBV suppression.
  • Patients with prior /current decompensation without history of prior HE.
    • No history of prior overt HE (defined as grade 2 or higher HE per West-Haven criteria requiring hospitalization, initiation or change of therapy).
    • History of any of the other decompensating events as above.
    • Control of underlying disease etiology should be at least 3 months prior:
      • Alcohol abstinence.
      • SVR for HCV.
      • HBV suppression.
  • Patients with prior/current decompensation with history of prior HE.
    • History of prior overt HE (defined as grade 2 or higher HE per West-Haven criteria requiring hospitalization, initiation or change of therapy), OR
    • Currently on therapy for HE, OR
    • Ascites especially refractory ascites.
    • With or without other prior variceal bleeding.
    • Control of underlying disease etiology should be at least 3 months prior:
      • Alcohol abstinence;
      • SVR for HCV;
      • HBV suppression.

Exclusion Criteria: 

  • Unclear diagnosis of cirrhosis.
  • Unable to provide informed consent, follow-up or provide samples
  • On hospice..
  • Acute Alcoholic hepatitis.
  • Active malignancy other than HCC.
  • HCC outside Milan criteria.
  • End-stage organ disease in other organs:
    • On dialysis;
    • On home oxygen;
    • Systolic CHF with EF< 40%.
  • Inpatient status.
  • Prior bariatric surgery.
  • Prior bone marrow or solid organ transplant.
  • HIV infection.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Patrick Kamath, M.D.

Open for enrollment

Contact information:

Amy Olofson R.N.

(507) 284-2638

Olofson.Amy@mayo.edu

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Hugo Vargas, M.D.

Open for enrollment

Contact information:

Megan Kelly M.H.A.

(480) 342-1248

Kelly.Megan1@mayo.edu

More information

Publications

Publications are currently not available