Nutritional intervention for treating muscle loss in cirrhotic patients with fluid retention
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
This study tests whether a special nutrition plan can help people with liver cirrhosis and muscle loss feel better and live longer after a specific procedure.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies Academic / other |
| Locations | 2 sites (Palermo and 1 other locations) |
| Trial ID | NCT06814626 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of a 12-week nutritional intervention on patients with liver cirrhosis and refractory ascites who are candidates for transjugular intrahepatic portosystemic shunt (TIPS) placement. The study focuses on individuals diagnosed with sarcopenia, characterized by reduced muscle mass, and aims to evaluate how nutritional support can improve their survival rates post-TIPS. Participants will receive tailored nutritional treatments, including dietary guidance and monitoring of food intake, to assess the effectiveness of these interventions on their clinical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with liver cirrhosis, refractory ascites, and confirmed sarcopenia.
Not a fit: Patients with severe hepatic insufficiency, significant heart or lung conditions, or poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve survival rates and quality of life for patients with liver cirrhosis and sarcopenia.
How similar studies have performed: Other studies have shown promising results with nutritional interventions in similar patient populations, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * severe hepatic insufficiency (bilirubin\> 5 mg/dl, MELD score\> 18, Child-Pugh score\> 9) * 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) * Chronic renal failure (creatinine\> 3 mg/dl) * Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG) * History of grade III-IV hepatic encephalopathy or West Haven grade I-II hepatic encephalopathy episodes within the last 3 months * Uncontrolled systemic sepsis * Presence of Hepatocellular carcinoma * Complete portal vein thrombosis * Active bleeding from gastroesophageal varices. Patients with adequately treated gastroesophageal varices can be included in the study (banding ligation, sclerotherapy) * Diagnosis of extra hepatic neoplasia * Transplant recipients * Patients unable or unwilling to comply with the protocol requirements * Pregnant or lactating women * Patients unable to autonomously express their consent (incapable patients) * any other laboratory condition or result that in the opinion of the Principal Investigator, preclude the subject's participation in the study
Where this trial is running
Palermo and 1 other locations
- IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione — Palermo, Italy (Recruiting)
- University Clinic for Visceral Surgery and Medicine, Inselspital — Bern, Switzerland (Recruiting)
Study contacts
- Study coordinator: Angelo Luca, Radiologist
- Email: aluca@ismett.edu
- Phone: +39 0912192468
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.