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
Recruiting
Phase 3
Interventional Study
Liver Cirrhosis
Refractory Ascites in Patients With Cirrhosis
Sarcopenia in Liver Cirrhosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 80
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 72 (estimated)
- Sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies · Other
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About This Trial
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…
Trial Locations
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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…
Contacts