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

Launched by THE MEDITERRANEAN INSTITUTE FOR TRANSPLANTATION AND ADVANCED SPECIALIZED THERAPIES · Feb 6, 2025

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ClinConnect Summary

This clinical trial is studying the effects of a special nutrition program on patients with liver cirrhosis who have a condition called refractory ascites, which means they have fluid buildup in their abdomen that doesn’t respond to standard treatments. The goal is to see if this nutritional support, given for 12 weeks after a procedure called TIPS (which helps improve blood flow in the liver), can help these patients live longer without needing a liver transplant. The researchers believe that improving nutrition may lead to better health outcomes for these patients, who are at a high risk of death within six months after undergoing the TIPS procedure.

To participate in this trial, individuals need to be between 18 and 80 years old, diagnosed with liver cirrhosis and refractory ascites, and have a specific measure of muscle loss (sarcopenia) confirmed by a scan. Those who meet these criteria will be required to sign an informed consent form. Participants can expect to receive tailored nutritional support after their TIPS procedure and will be monitored closely to evaluate how well they do over the following months. It’s important to note that some individuals, like those with severe heart or kidney problems, or certain other serious conditions, may not be eligible for this study.

Gender

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Eligibility criteria

• 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