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 (NS-TIPS)

February 7, 2025 updated by: The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

72

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Angelo Luca, Radiologist
  • Phone Number: +39 0912192468
  • Email: aluca@ismett.edu

Study Contact Backup

  • Name: Monica Rizzo, Study Coordinator
  • Phone Number: +39 0912192692
  • Email: morizzo@ismett.edu

Study Locations

  • Italy
      • Palermo, Italy, 90127
        • Recruiting
        • IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
        • Contact:
          • Monica Rizzo, Study Coordinator
          • Phone Number: +39 091 2192 692
          • Email: morizzo@ismett.edu
  • Switzerland
      • Bern, Switzerland, 3010
        • Recruiting
        • University Clinic for Visceral Surgery and Medicine, Inselspital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 12 weeks post-TIPS nutritional dietary intervention
Dietary supplement: 12-week nutritional intervention with Friliver dispensing
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.
Other: 12-week nutritional intervention with personalized diet
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.
Other: 12-week nutritional intervention with diet diary to report foods eaten.
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.
No Intervention: Standard clinical practice: follow-up post-TIPS placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
From enrollment to 6 months after TIPS.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2022

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2025

Study Registration Dates

First Submitted

January 28, 2025

First Submitted That Met QC Criteria

February 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 7, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRRB/31/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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