Liver CirrhosisPhase 3NS-TIPSNCT06814626
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
A Phase 3 study testing 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with personalized diet and 12-week nutritional intervention with diet diary to report foods eaten. in people with Liver Cirrhosis and Refractory Ascites in Patients With Cirrhosis, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
- What is being tested?
- 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with personalized diet and 12-week nutritional intervention with diet diary to report foods eaten.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 13 Oct 2022to Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Italy1 site, 1 recruiting
- Recruiting
IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione
Palermo, 90127
Monica Rizzo, Study Coordinator, +39 091 2192 692, morizzo@ismett.edu
Switzerland1 site, 1 recruiting
- Recruiting
University Clinic for Visceral Surgery and Medicine, Inselspital
Bern, 3010
Annalisa Berzigotti, +41 31 632 33 91, annalisa.berzigotti@insel.ch
About this study
Official title: Role of Nutritional Intervention With Friliver 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.
- Conditions
- Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
- Being tested
- 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with personalized diet, 12-week nutritional intervention with diet diary to report foods eaten.
- Keywords
- nutritional treatment, sarcopenia, liver cirrhosis, refractory ascites, transjugular intrahepatic portosystemic shunt placement, TIPS
- Medical subject headings
- Liver Cirrhosis, Sarcopenia, Ascites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
12-week nutritional intervention with Friliver dispensingDietary supplement
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
12-week nutritional intervention with personalized dietOther
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
12-week nutritional intervention with diet diary to report foods eaten.Other
After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day.
| Study group | Role | What they receive |
|---|---|---|
| 12 weeks post-TIPS nutritional dietary intervention | Experimental | Not described Receives: Dietary Supplement: 12-week nutritional intervention with Friliver dispensing; Other: 12-week nutritional intervention with personalized diet; Other: 12-week nutritional intervention with diet diary to report foods eaten. |
| Standard clinical practice: follow-up post-TIPS placement. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to 6 months after TIPS.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2025
- Study start13 Oct 2022
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized Therapies
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06814626
- Sponsor's protocol ID
- IRRB/31/20
- Acronym
- NS-TIPS
- Status last verified
- Mar 2026
- First submitted
- 28 Jan 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Nutritional Intervention With Friliver 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
- ClinicalTrials.gov ID
- NCT06814626
- Acronym / sponsor ID
- NS-TIPS / IRRB/31/20
- Conditions
- Liver Cirrhosis, Refractory Ascites in Patients With Cirrhosis, Sarcopenia in Liver Cirrhosis
- Keywords
- nutritional treatment, sarcopenia, liver cirrhosis, refractory ascites, transjugular intrahepatic portosystemic shunt placement, TIPS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- The Mediterranean Institute for Transplantation and Advanced Specialized TherapiesUniversity, hospital or other
- Study start
- 13 Oct 2022 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 weeks post-TIPS nutritional dietary intervention | Experimental | Dietary Supplement: 12-week nutritional intervention with Friliver dispensing, Other: 12-week nutritional intervention with personalized diet, Other: 12-week nutritional intervention with diet diary to report foods eaten. |
| Standard clinical practice: follow-up post-TIPS placement. | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 12-week nutritional intervention with Friliver dispensingAfter TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day. | Dietary supplement | 12 weeks post-TIPS nutritional dietary intervention |
| 12-week nutritional intervention with personalized dietAfter TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day. | Other | 12 weeks post-TIPS nutritional dietary intervention |
| 12-week nutritional intervention with diet diary to report foods eaten.After TIPS placement patients of the treatment group receive a 12-week nutritional intervention that includes a personalized diet, Friliver dispensing (Dompé; 2 sachets 3 times a day) and a diet diary to report the quantity and quality of the foods eaten every single day. | Other | 12 weeks post-TIPS nutritional dietary intervention |
Primary outcome
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.
Time frame: From enrollment to 6 months after TIPS.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 12-week nutritional intervention with Friliver dispensing, 12-week nutritional intervention with personalized diet and 12-week nutritional intervention with diet diary to report foods eaten. in people with Liver Cirrhosis and Refractory Ascites in Patients With Cirrhosis, run by The Mediterranean Institute for Transplantation and Advanced Specialized Therapies at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Angelo Luca, Radiologist (+39 0912192468, aluca@ismett.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: From enrollment to 6 months after TIPS.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.