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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

Study acronym: NS-TIPS
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary and study completion dates: Dec 2025 to Dec 2027v3
  2. Interventions: 12-week nutritional intervention with personalized diet, Friliver dispensing and a diet diary to report foods eaten. (Dietary Supplement) to 12-week nutritional intervention with Friliver dispensing (Dietary Supplement), 12-week nutritional intervention with diet diary to report…v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06814626
Lead Sponsor The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
Conditions
(from sponsor)		 Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
Related terms Ascites, Liver Cirrhosis, Sarcopenia
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov