Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
Conditions
Keywords
nutritional treatment, sarcopenia, liver cirrhosis, refractory ascites, transjugular intrahepatic portosystemic shunt placement, TIPS
Brief summary
The hypothesis is that in patients with cirrhosis and refractory ascites candidate to TIPS, and sarcopenia (identified by a PMA ≤16 cm² at the level of L3), who are at high-risk of 6-month mortality after TIPS placement, a post-TIPS 12 weeks nutritional intervention is associated with improved post-TIPS prognosis. The primary objective is to evaluate the effect of a post-TIPS 12 weeks nutritional intervention on liver transplant-free six-month survival in sarcopenic candidates to TIPS for refractory ascites in cirrhosis.
Interventions
DIETARY_SUPPLEMENT12-week nutritional intervention with Friliver dispensing
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
OTHER12-week nutritional intervention with personalized diet
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
OTHER12-week nutritional intervention with diet diary to report foods eaten.
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
Sponsors
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* men and women with an age ≥ 18 and ≤ 80 years * clinical, radiological or histological diagnosis of liver cirrhosis * diagnosis of RA * confirmation of sarcopenia defined in CT scan as the sum of the psoas muscle areas measured at the level of the 3rd lumbar vertebra (PMA) ≤16 cm2 * informed consent signed
Exclusion criteria
* severe hepatic insufficiency (bilirubin\> 5 mg/dl, MELD score\> 18, Child-Pugh score\> 9) * Congestive heart failure class ≥2 according to New York Heart Association criteria (NYHA) * Active coronary heart disease (myocardial infarction within 6 months of the study) * Severe pulmonary hypertension suspected on echocardiogram (systolic pulmonary arterial pressure \[PAPs\]\> 35 mmHg) and confirmed with right cardiac catheterization (PAPs\> 45mmHg) * Chronic renal failure (creatinine\> 3 mg/dl) * Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG) * History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months * Uncontrolled systemic sepsis * Presence of Hepatocellular carcinoma * Complete portal vein thrombosis * Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy) * Diagnosis of extra hepatic neoplasia * Transplant recipients * Patients unable or unwilling to comply with the protocol requirements * Pregnant or lactating women * Patients unable to autonomously express their consent (incapable patients) * any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of survival at 6 months after TIPS assessed using Kaplan-Meier curves. The difference between the survival of the two groups (control and treatment) will be calculated using a Log-Rank test. | From enrollment to 6 months after TIPS. |
Countries
Italy, Switzerland
Contacts
CONTACTAngelo Luca, Radiologist
CONTACTMonica Rizzo, Study Coordinator
Outcome results
None listed