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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
12 weeks post-TIPS nutritional dietary intervention
干预措施: 12-week nutritional intervention with Friliver dispensing (Dietary Supplement)
12 weeks post-TIPS nutritional dietary intervention
干预措施: 12-week nutritional intervention with personalized diet (Other)
12 weeks post-TIPS nutritional dietary intervention
干预措施: 12-week nutritional intervention with diet diary to report foods eaten. (Other)
Standard clinical practice: follow-up post-TIPS placement.
结局指标
主要结局
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.
时间窗: From enrollment to 6 months after TIPS.
次要结局
未报告次要终点