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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe Mediterranean Institute for Transplantation and Advanced Specialized Therapies

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • 12-week nutritional intervention with Friliver dispensing
  • 12-week nutritional intervention with personalized diet
  • 12-week nutritional intervention with diet diary to report foods eaten.

Treatment groups

72 Participants
are divided into 2 treatment groups