NCT06814626 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
| NCT ID | NCT06814626 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | The Mediterranean Institute for Transplantation and Advanced Specialized Therapies |
| Condition | Liver Cirrhosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2022-10-13 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 72 participants in total. It began in 2022-10-13 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06814626 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Liver Cirrhosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06814626 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 72 participants.
Is NCT06814626 currently recruiting?
Yes, NCT06814626 is actively recruiting participants. Contact the research team at aluca@ismett.edu for enrollment information.
Where is the NCT06814626 trial being conducted?
This trial is being conducted at Palermo, Italy, Bern, Switzerland.
Who is sponsoring the NCT06814626 clinical trial?
NCT06814626 is sponsored by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies. The trial plans to enroll 72 participants.