Skip to main content
OpenTrials
Recruiting

NCT Number: 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

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

12-week nutritional intervention with Friliver dispensing

Dietary Supplement

After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.

12-week nutritional intervention with personalized diet

Other

After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.

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

Other

After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.

Primary outcomes

  1. 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.

    Time frame: From enrollment to 6 months after TIPS.

Study contacts

Contact information is provided by the study sponsor or research team.

Angelo Luca, Radiologist

CONTACT

[email protected]

+39 0912192468

Monica Rizzo, Study Coordinator

CONTACT

[email protected]

+39 0912192692

Sponsors and collaborators

Lead sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Other

Registry information

Official study 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

Acronym: NS-TIPS

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 7, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.