Actively 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
Led by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Updated on 2025-02-11
72
Participants Needed
2
Research Sites
163 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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
- Sarcopenia confirmed by CT scan with psoas muscle area 16 cm² or less at the third lumbar vertebra
- 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 2 or higher by NYHA criteria
- Active coronary heart disease (heart attack within 6 months)
- Severe pulmonary hypertension confirmed by heart tests
- Chronic kidney failure (creatinine > 3 mg/dl)
- Poor performance status (ECOG score 2 or higher)
- Recent severe or moderate hepatic encephalopathy episodes within 3 months
- Uncontrolled systemic infection
- Presence of liver cancer
- Complete portal vein thrombosis
- Active bleeding from gastroesophageal varices (unless treated)
- Diagnosis of cancer outside the liver
- Previous organ transplant recipients
- Unable or unwilling to follow study requirements
- Pregnant or breastfeeding women
- Unable to give informed consent
- Any other medical condition preventing participation as judged by the study doctor
AI-Screening
AI-Powered Screening
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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
CONTACT
M
Monica Rizzo, Study Coordinator
CONTACT
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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