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

NCT06814626 | Recruiting Phase 3

• 1 other identifier: IRRB/31/20
• Study Type: interventional
• Target: 72
• Locations: 2 countries
• Sites: 2

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.

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

Outcome Measures

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.

  From enrollment to 6 months after TIPS.

Study Arms (2)

12 weeks post-TIPS nutritional dietary intervention

EXPERIMENTAL

Dietary Supplement: 12-week nutritional intervention with Friliver dispensing; Other: 12-week nutritional intervention with personalized diet; Other: 12-week nutritional intervention with diet diary to report foods eaten.

Standard clinical practice: follow-up post-TIPS placement.

NO INTERVENTION

Interventions

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 weeks post-TIPS nutritional dietary intervention

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 weeks post-TIPS nutritional dietary intervention

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.

12 weeks post-TIPS nutritional dietary intervention

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Mediterranean Institute for Transplantation and Advanced Specialized Therapies: lead

Study Sites (2)

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

Palermo, 90127, Italy

RECRUITING

University Clinic for Visceral Surgery and Medicine, Inselspital

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis; Sarcopenia; Ascites

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Signs and Symptoms

Central Study Contacts

Angelo Luca, Radiologist

CONTACT

+39 0912192468; aluca@ismett.edu

Monica Rizzo, Study Coordinator

CONTACT

+39 0912192692; morizzo@ismett.edu

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 7, 2025
• Study Start: October 13, 2022
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 11, 2025

Record last verified: 2025-01

Locations

CH (1); IT (1)