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New treatment option for Liver Cirrhosis
Official title 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
ClinicalTrials.gov ID: NCT06814626
What this study is testing
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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
You likely can't join if
- 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...
- Chronic renal failure (creatinine\> 3 mg/dl)
- Performance status ≥2 according to the Eastern Cooperative Oncology Group scale (ECOG)
See the full eligibility 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
- 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 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
The study team makes the final eligibility decision.
Where it's taking place
- Palermo, Italy
- Bern, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Palermo, Italy; Bern, Switzerland. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.