Clinical trial NCT06814626: 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
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Liver Cirrhosis
Refractory Ascites in Patients with Cirrhosis
Sarcopenia in Liver Cirrhosis
Keywords: nutritional treatment
sarcopenia
liver cirrhosis
refractory ascites
transjugular intrahepatic portosystemic shunt placement
TIPS
Lead sponsor: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Sponsor class: OTHER
First posted: 2025-02-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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

Primary outcomes:
measure: Rate of survival at 6 months after TIPS assessed using Kaplan-Meier curves. The difference between the survival of the two groups (control and treatment) will be calculated using a Log-Rank test.
timeFrame: From enrollment to 6 months after TIPS.
Secondary outcomes:
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
city: Bern
country: Switzerland
facility: University Clinic for Visceral Surgery and Medicine, Inselspital
Study officials:
References: