Overview
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.
Eligibility
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