Evaluation of Minimal Hepatic Encephalopathy in Patients With Cirrhosis and Portal Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 82
- 试验地点
- 4
- 主要终点
- Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis
研究概览
简要总结
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known. The main objective of this study is to evaluate the MHE in patients with cirrhosis and portal hypertension.
详细描述
Minimal hepatic encephalopathy (MHE) is a subclinical cognitive impairment and represents the mildest type of hepatic encephalopathy (HE). It is a frequent complication of the liver disease, affecting up to 80% of tested patients. MHE affects severely the lives of patients by altering their quality-of-life and their socioeconomic status and is strongly associated to the development of overt HE. Portal hypertension is the main complication of cirrhosis and is responsible of severe complications such as HE. The consequence of portal hypertension is the formation of the spontaneous portosystemic shunts (SPSS). Their presence has been associated with recurrent or persistent HE. The relationship between the SPSS and their characteristics and the prevalence of MHE in patient with cirrhosis is poorly known.
Patients with compensated cirrhosis and portal hypertension will be considered for inclusion. After written inform consent, the serum ammonia, psychometric hepatic encephalopathy score (PHES) and the animal naming test (ANT) will be performed to evaluate the presence of MHE. Patients diagnosed with MHE will be treated and a new evaluation will be performed 6 months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Patient with cirrhosis and portal hypertension older than 18 old
- •Patient who underwent a CT scan or MRI in the last 3 months
- •The Mini-Mental State (MMS) test >
- •Patient capable of receiving and understanding information relating to the study and of giving his written informed consent.
- •Patient affiliated to the French social security system
排除标准
- •Cirrhotic patient with overt HE or history of persistent or recurrent HE.
- •Hepatocellular carcinoma beyond Milan criteria.
- •Portal vein thrombosis.
- •Previous transjugular intrahepatic portosystemic shunt (TIPS) or surgical shunt.
- •Presence of neurological or psychiatric disorder.
- •Patient with treatment by benzodiazepines or opioid substitution.
- •Pregnant or nursing women
- •Patient in exclusion period of a previous study
- •Patient under guardianship, trusteeship or the protection of justice or incapable of giving their own informed consent
研究组 & 干预措施
Patients with compensated cirrhosis and portal hypertension
干预措施: Assessment of Minimal hepatic encephalopathy (MHE) (Diagnostic Test)
结局指标
主要结局
Evaluation of MHE in patients with cirrhosis and portal hypertension by serum ammonia analysis
时间窗: Day 1
The serum ammonia analysis measures the level of ammonia in the blood, expressed in micromoles per liter. Average values in venous blood are between 11,2 and 48,2 micromoles per liter.
Evaluation of MHE in patients with cirrhosis and portal hypertension by the animal naming test (ANT)
时间窗: Day 1
The animal naming test (ANT) is an analysis of semantic fluency consisting of saying as many animal names as possible within one minute. The French recommendations developed by the French Association for The Liver Study (AFEF) suggests a limit of 20 animal names in 1 min. Below, the existence of MHE is likely.
Evaluation of MHE in patients with cirrhosis and portal hypertension by the psychometric hepatic encephalopathy score (PHES)
时间窗: Day 1
The psychometric hepatic encephalopathy score (PHES) is composed of five tests, number connection test-A (NCT-A), number connection test-B (NCT-B), serial dotting test (SDT), line tracing test (LTT) and digit symbol test (DST). The results of the NCT-A, NCT-B, and SDT were measured as seconds, including the time needed to correct any errors, and the result of DST was measured as points. The results of the LTT were measured as both the time needed to complete the test (LTTt, seconds) and as the error score (LTTe), LTT = (1 + LTTe/100) × LTTt. Accordingly, a higher result of DST equals better performance, and lower results on the other tests equal better performance. The final score of PHES is generated from the sum of the scores of five tests, which ranged between +5 and -15. The result of the PHES is expressed in number of standard deviations (SD) from a population matched on age and level of education. A threshold (- 4DS) defines the EHM according to current recommendations.
次要结局
- Evaluation of the correlation between MHE and portal hypertension by the mean of blood test and abdominal imaging(1 month)
- Evaluation of the correlation between MHE and splenic congestion by elastography(Day 1)
- Evaluation of the correlation between MHE and liver fibrosis by elastography(Day 1)
- Evaluation of the correlation between MHE and sarcopenia by imaging(Day 1)
- Evaluation of the correlation between MHE and myosteatosis by imaging(Day 1)
- Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by serum ammonia analysis(Month 7)
- Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the psychometric hepatic encephalopathy score (PHES)(Month 7)
- Evaluation of the neurologic assessment in patients diagnosed with MHE after 6 months of treatment by the animal naming test (ANT)(Month 7)