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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

• informed consent signed

Locations
Other Locations
Italy
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
RECRUITING
Palermo
Switzerland
University Clinic for Visceral Surgery and Medicine, Inselspital
RECRUITING
Bern
Contact Information
Primary
Angelo Luca, Radiologist
aluca@ismett.edu
+39 0912192468
Backup
Monica Rizzo, Study Coordinator
morizzo@ismett.edu
+39 0912192692
Time Frame
Start Date: 2022-10-13
Estimated Completion Date: 2025-12
Participants
Target number of participants: 72
Treatments
Experimental: 12 weeks post-TIPS nutritional dietary intervention
No_intervention: Standard clinical practice: follow-up post-TIPS placement.
Related Therapeutic Areas
Sponsors
Leads: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

This content was sourced from clinicaltrials.gov