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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

Phase 3
Recruiting
Conditions
Refractory Ascites in Patients with Cirrhosis
Sarcopenia in Liver Cirrhosis
Liver Cirrhosis
Registration Number
NCT06814626
Lead Sponsor
The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
72
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod

Trial Locations

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

IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
🇮🇹Palermo, Italy
Monica Rizzo, Study Coordinator
Contact
+39 091 2192 692
morizzo@ismett.edu

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