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Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome
Sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
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.
Official title: Role of Nutritional Intervention with Friliver for the Treatment of Sarcopenia in Cirrhotic Patients with Refractory Ascites Candidate to Transjugular Intrahepatic Portosystemic Shunt Placement and Identification of Prognostic Factors Related to Clinical Outcome
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
72
Start Date
2022-10-13
Completion Date
2025-12
Last Updated
2025-02-11
Healthy Volunteers
No
Interventions
12-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.
12-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.
12-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.
Locations (2)
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, Italy
University Clinic for Visceral Surgery and Medicine, Inselspital
Bern, Switzerland