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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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

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

NCT06814626•The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

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
+7 more criteria

Locations (2)

IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione

Palermo, Italy

University Clinic for Visceral Surgery and Medicine, Inselspital

Bern, Switzerland

Key Dates

Start Date

October 13, 2022

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

February 11, 2025

Enrollment

ESTIMATED participants

Conditions

Liver CirrhosisRefractory Ascites in Patients with CirrhosisSarcopenia in Liver Cirrhosis

Interventions

12-week nutritional intervention with Friliver dispensing

DIETARY_SUPPLEMENT

12-week nutritional intervention with personalized diet

OTHER

12-week nutritional intervention with diet diary to report foods eaten.

OTHER

Contacts

Angelo Luca, Radiologist

CONTACT

+39 0912192468 aluca@ismett.edu

Monica Rizzo, Study Coordinator

CONTACT

+39 0912192692 morizzo@ismett.edu

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

NCT06169592

Liver CirrhosisLiver Transplant; Complications

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RECRUITING

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

NCT07275554

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 11, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

Verification of Risk Factors of Thrombohemorrhagic Complications in Recipients After Related Liver Transplantation

Analysis of Methylomic Features and Prognostic Risk Prediction in Patients With Hepatitis B-related Acute-on-chronic Liver Failure

Validation of New Prognostic Biomarkers in Patients With Decompensated Cirrhosis

Stop of Proton-pump Inhibitor Treatment in Patients With Liver Cirrhosis - a Double-blind, Placebo-controlled Trial

DOAC in Patients with Child a or B Liver Cirrhosis

Endothelin Receptor Antagonism With Ambrisentan to Treat Hepatorenal Syndrome