Actively Recruiting
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
Led by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Updated on 2025-02-11
72
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating whether a 12-week nutritional intervention after Transjugular Intrahepatic Portosystemic Shunt (TIPS) placement can improve six-month survival without liver transplant in patients with cirrhosis who have refractory ascites and sarcopenia. Sarcopenia is identified by measuring muscle mass on a CT scan. This study focuses on patients at high risk of death within six months after TIPS, aiming to understand if nutrition support can impact their prognosis. Participants will be randomly assigned to receive either the nutritional intervention or standard clinical follow-up after TIPS placement. The nutritional intervention includes a personalized diet, Friliver dietary supplement taken as two sachets three times daily, and a diet diary to track food intake over 12 weeks. The control group will follow standard post-TIPS care without this additional nutritional support. Throughout the study, researchers will monitor survival rates over six months using statistical analysis to compare both groups. Patients will be assessed from enrollment through six months post-TIPS to measure the primary outcome of liver transplant-free survival. The study is sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies and will enroll adults aged 18 to 80 years with specific liver conditions and sarcopenia.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women aged 18 to 80 years
- Clinical, radiological, or histological diagnosis of liver cirrhosis
- Diagnosis of refractory ascites
- Confirmation of sarcopenia by CT scan showing psoas muscle area at L3 level 64 16 cm2
- Signed informed consent
You will not qualify if you...
- Severe liver failure (bilirubin > 5 mg/dl, MELD score > 18, Child-Pugh score > 9)
- Congestive heart failure class 652 by NYHA criteria
- Active coronary heart disease within 6 months
- Severe pulmonary hypertension confirmed by catheterization
- Chronic kidney failure (creatinine > 3 mg/dl)
- Poor performance status (ECOG 652)
- Recent or severe hepatic encephalopathy
- Uncontrolled systemic infection
- Hepatocellular carcinoma
- Complete portal vein thrombosis
- Active bleeding from gastroesophageal varices unless treated
- Diagnosis of extrahepatic cancer
- Liver transplant recipients
- Unable or unwilling to follow study protocol
- Pregnant or breastfeeding women
- Unable to give informed consent
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants receive a 12-week nutritional intervention after TIPS placement, which includes a personalized diet, Friliver supplement intake, and maintaining a diet diary to report daily food intake.
Regular visits during the 12-week intervention period
Duration - Up to 6 months after TIPS placement
Participants are followed up to assess survival and clinical outcomes for 6 months after TIPS placement.
Periodic follow-up visits for up to 6 months
Trial Site Locations
Total: 2 locations
1
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, Italy, 90127
Actively Recruiting
2
University Clinic for Visceral Surgery and Medicine, Inselspital
Bern, Switzerland, 3010
Actively Recruiting
Research Team
A
Angelo Luca, Radiologist
M
Monica Rizzo, Study Coordinator
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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