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)

The Mediterranean Institute for Transplantation and Advanced Specialized Therapies

Status and phase: Enrolling; Phase 3

Conditions: Refractory Ascites in Patients with Cirrhosis; Liver Cirrhosis; Sarcopenia in Liver Cirrhosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06814626

IRRB/31/20

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No 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
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 2 patient groups

12 weeks post-TIPS nutritional dietary intervention

Experimental group

Treatment:

Other: 12-week nutritional intervention with personalized diet

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

Dietary Supplement: 12-week nutritional intervention with Friliver dispensing

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

No Intervention group