Prediction of Post-TIPS Hepatic Encephalopathy in Patients With Liver Cirrhosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Prediction of post-TIPS HE using established tests
研究概览
简要总结
Prediction of hepatic encephalopathy after insertion of a transjugular intrahepatic portosystemic stent shunt (post-TIPS HE) are critical for patient selection prior to TIPS insertion, and a currently unmet, clinically highly relevant need. In this prospective multicenter observational cohort study, the investigators aim to evaluate the ability of Stroop EncephalApp and the simplified Animal Naming Test (S-ANT1) in comparison to the goldstandard PHES to predict the occurence of post-TIPS HE in patients with decompensated liver cirrhosis. Moreover, secondary aims of this study include the detection of potential blood based biomarkers for prediction of post-TIPS HE and the predictive value of frailty and quality of life/sleep prior to TIPS insertion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Liver cirrhosis (clinical, sonographic, CT-morphological, laparoscopic or histological)
- •TIPS indication: refractory ascites or secondary prophylaxis after variceal bleeding
- •Age ≥ 18 years
- •Ability to give consent
- •Consent to the study after comprehensive information
排除标准
- •Contraindication against TIPS insertion
- •Lack of consent
- •History of liver transplantation
- •Preemptive TIPS
- •Emergency TIPS
- •Severe neurological comorbidities
结局指标
主要结局
Prediction of post-TIPS HE using established tests
时间窗: 12 months
Evaluation of the predictive value of S-ANT1 and Stroop EncephalApp compared with PHES (gold standard) for predicting post-TIPS HE within the first 12 months after TIPS implantation.
次要结局
- Longitudinal assessment of health-related quality of life using the Chronic Liver Disease Questionnaire (CLDQ)(12 months)
- Longitudinal assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI)(12 months)
- Evaluation of the impact of frailty, assessed by the Liver Frailty Index (LFI) on the risk of post-TIPS HE.(12 months)
- Evaluation of candidate inflammatory biomarkers (using the Olink target 96 panel) for predicting of post-TIPS HE(12 months)
- Longitudinal assessment of cognitive function after TIPS insertion(12 months)
- Evaluation of serum Neurofilament Light Chains (sNfL) and Glial fibrillary acidic protein (GFAP) for predicting of post-TIPS HE(12 months)
研究者
Christian Labenz
Priv.-Doz. Dr. med.
Johannes Gutenberg University Mainz