Precision Medicine to Predict the Trajectory of Liver Cirrhosis: Prospective Cohort Study
Study Details
Study Description
Brief Summary
Preventing decompensation is a key endpoint in the management of compensate cirrhosis patients. The known factors that increases the risk of decompensation include the presence of clinically significant portal hypertension (CSPH) and the control of primary etiology of cirrhosis. Other factors which may influence the progression of cirrhosis included the presence of metabolic syndrome (diabetes mellitus and obesity), frailty, concomitant medications (statin, non-selective beta-blocker) were not well understood. Investigators aim to perform a pilot, observational study to study various baseline factors in relation to the clinical outcome of cirrhosis patients in a prospective follow up.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
All patient who fulfilled eligibility criteria will be consented and recruited. The study will last up to 3 years or up to 7 assessment and 7 visits All subjects will be followed every 6 monthly for study outcome from recruitment, biosamples (blood,urine and stool), elastography, quality of life questionnaire and frialty assessment were done at baseline. Completion of Sit to stand , handgrip and 6 minute walking test at baseline and Visit 3.All visits will be follow up on study outcome (liver-related events ,metabolic related outcome and cardiovascular related outcomes.). During decompensation (decrease in liver function ) .Collection of research leftover blood,urine and stool samples if applicable.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Liver cirrhosis with metabolic syndrome Liver cirrhosis patients with metabolic syndrome on standard treatment |
Diagnostic Test: liver and spleen stiffness test and laboratory test
Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)
|
| Liver cirrhosis without metabolic syndrome Liver cirrhosis patients without metabolic syndrome on standard treatment |
Diagnostic Test: liver and spleen stiffness test and laboratory test
Diagnosis of cirrhosis can be based on liver biopsy,radiological ,clinical or liver stiffness measurement (LMS)
|
Outcome Measures
Primary Outcome Measures
- Liver related events [3 years]
Determine the rate of liver related events with and without metabolic syndrome
Secondary Outcome Measures
- Progression of cirrhosis [3 years]
To determine the proportion of patients with cirrhosis progression (stage as defined by D' Amico method).
- Cardiovascular events [3 years]
Determine the rate of cardiovascular events with and without metabolic syndrome
- Baseline cirrhosis features [3 years]
Baseline differences (clinical, immunological and metabolomic differences) and liver stiffness and spleen stiffness measured using vibration on controlled transient elastography (in kPa) between cirrhosis patients with and without metabolic syndrome
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Aged 21 to 90 years with the diagnosis of liver cirrhosis (regardless of etiology)
-
Consent to participate in the study
Exclusion Criteria:
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Terminal malignancy. Subjects with prognosis < 3 months.
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Patient refusal or unable to commit to study follow-up
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Changi General Hospital | Singapore | Singapore | 529889 |
Sponsors and Collaborators
- Changi General Hospital
Investigators
- Principal Investigator: Yu Jun Wong, MD, Changi General Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
- Chang PE, Wong GW, Li JW, Lui HF, Chow WC, Tan CK. Epidemiology and Clinical Evolution of Liver Cirrhosis in Singapore. Ann Acad Med Singap. 2015 Jun;44(6):218-25.
- Harris PS, Hansen RM, Gray ME, Massoud OI, McGuire BM, Shoreibah MG. Hepatocellular carcinoma surveillance: An evidence-based approach. World J Gastroenterol. 2019 Apr 7;25(13):1550-1559. doi: 10.3748/wjg.v25.i13.1550.
- 2021/2815