RecruitingPhase 3NCT06814626

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

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


Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Enrollment

72 participants

Start Date

Oct 13, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with diet diary to report foods eaten., and others for people with liver cirrhosis, refractory ascites in patients with cirrhosis, and other related conditions. The study is currently recruiting participants at 2 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


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

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NCT06814626


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