Clinical Trial

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

Study acronym: NS-TIPS
Recruiting Phase 3
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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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-02-06; most recent amendment 2026-07-13.
Trial Details
NCT Number NCT06814626
Lead Sponsor The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
Enrollment 72 participants
Start Date 2022-10-13
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-07-14