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
Key facts
- Who runs it
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Where
- Italy and Switzerland2 sites in 2 countriesChoose a country to see its sites
- Trial code
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 72 people, planned
- Started
- 13 Oct 2022
- Expected to end
- Dec 2027
- Type of study
- Interventional, 2 groupsOne group gets no study treatment, for comparison.
- Treatments tested
- 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.
- Record updated
- 14 July 2026
Who can take part
- Age
- 18 years to 80 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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
Who cannot take part
- Transplant recipients
- 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)
- History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months
- Complete portal vein thrombosis
- Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy)
- severe hepatic insufficiency (bilirubin> 5 mg/dl, MELD score> 18, Child-Pugh score> 9)
- Chronic renal failure (creatinine> 3 mg/dl)
- any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study
- Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG)
- Uncontrolled systemic sepsis
- Presence of Hepatocellular carcinoma
- Diagnosis of extra hepatic neoplasia
- Patients unable or unwilling to comply with the protocol requirements
- Pregnant or lactating women
- Patients unable to autonomously express their consent (incapable patients)
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 80 years old?
This trial has no sites in United States.
It has sites in 2 countries. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- 12 weeks post-TIPS nutritional dietary interventionTreatment being tested
Treatment: 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with personalized diet, and 12-week nutritional intervention with diet diary to report foods eaten.
- Standard clinical practice: follow-up post-TIPS placement.No study treatment, for comparison
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- 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
- Fit questions
- Built from NCT06814626, who can take part
- Record updated
- 14 July 2026