Status: Recruiting
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
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.
Participants needed: 72
Trial details
Phase: Phase 3Age: 18-80Biological sex: AllType: InterventionalSponsor: The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUpdated: Feb 11, 2025Locations: 2
Eligibility criteria
men and women with an age ≥ 18 and ≤ 80 years [+4]
severe hepatic insufficiency (bilirubin> 5 mg/dl, MELD score> 18, Child-Pugh sco... [+16]