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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
72
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.
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.
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.
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, Italy
RECRUITINGUniversity Clinic for Visceral Surgery and Medicine, Inselspital
Bern, Switzerland
RECRUITINGRate 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.
Time frame: From enrollment to 6 months after TIPS.
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