Hepatic Encephalopathy
Conditions
Keywords
Hepatic Encephalopathy, Diet Management, Transjugular Intrahepatic Portosystemic Shunt
Brief summary
Hepatic encephalopathy is a severe complication of transjugular intrahepatic portosystemic shunt (TIPS) treatment in patients with cirrhosis and variceal bleeding. This study is specially designed to explore whether diet management strategy could decrease incidence of encephalopathy after TIPS treatment.
Detailed description
Hepatic encephalopathy (HE) is a severe complication of TIPS treatment in patients with cirrhosis and variceal bleeding. The overall incidence of post-TIPS encephalopathy ranges between 10% and 50%, and even the percentage of the new or worsened HE was evaluated up to 13-36%. No approach or medication was evidenced for prophylaxis of post-TIPS encephalopathy, including lactulose and rifaximin. Diet management has been used as an important part of the prophylaxis and treatment strategy for patients with metabolic diseases like diabetes and nephritis, which has drawn increasing interest of clinicians. Nevertheless, there is still no standard consensus or even recommendation for patients after TIPS procedure for now, which worsened malnutrition and affected survival. Thus, this study is specially designed to explore whether diet management strategy, drawn up from the nutritional management consensus of hepatic encephalopathy (ISHEN consensus), could decrease incidence of encephalopathy after TIPS treatment of the patient with cirrhosis and variceal bleeding.
Interventions
DIETARY_SUPPLEMENTdiet management strategy for encephalopathy
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
Sponsors
West China Hospital
Li Yang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* patients with decompensated liver cirrhosis regardless of the etiology * acute variceal bleeding or with history of variceal bleeding evidenced by endoscopy * an age between 18 and 75 years old
Exclusion criteria
* a total bilirubin level more than 3mg/dL (51.3mmol/L) * a creatinine level greater than 3 mg/dL(265umol/L) * severe dysfunction of heart and respiratory system * pregnancy * uncontrolled neoplasm * active systemic infection * history of any kind of encephalopathy, mental disease, alcohol dependence, or any other status that influence brain function * diabetes or any other metabolic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Hepatic Encephalopathy | 1 year | incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Liver Transplantation-free Survival Rate | 1 year | survival rate free of liver transplantation within 1 year after enrollment |
| Incidence of Stent Dysfunction | 1 year | Narrowing or even complete occlusion of the stent, evidenced by imaging examination and/or upper gastrointestinal endoscopy, with or without clinic symptoms. |
| Incidence of Portal Hypertension Related Severe Complications | 1 year | Incidence of severe complications of portal hypertension, especially for failure of control of acute variceal bleeding and clinical significant rebleeding. |
| Change of Nutritional Status | 1 year | Human body components analysis, evaluated by score of the Inbody Test. |
| Change of Quality of Life | 1 year | Health related quality of life, assessed by score of the widely used questionaire Short Form 36. |
Countries
China
Contacts
Primary ContactLi Yang, MD
Backup ContactYongjun Zhu, Doctor
Outcome results
None listed