Role of Nutritional Intervention for the Treatment of Sarcopenia in Cirrhotic Patients with Refra… (NCT06814626) | Clinical Trial Compass
RecruitingPhase 3
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
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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 lacta…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of survival at 6 months after TIPS assessed using Kaplan-Meier curves. The difference between the survival of the two groups (control and treatment) will be calculated using a Log-Rank test.
Timeframe: From enrollment to 6 months after TIPS.
Trial details
NCT IDNCT06814626
SponsorThe Mediterranean Institute for Transplantation and Advanced Specialized Therapies