Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Diet Management on Incidence of Hepatic Encephalopathy of Patients With Cirrhosis and Variceal Bleeding After Transjugular Intrahepatic Portosystemic Shunt Treatment

Conditions
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Hepatic Encephalopathy

Intervention / Treatment
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* Dietary Supplement: diet management strategy for encephalopathy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nutritional management group<br>diet management strategy for encephalopathy | Dietary Supplement: diet management strategy for encephalopathy<br>* diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.<br>|
| No Intervention: control group<br>Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Hepatic Encephalopathy | incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver Transplantation-free Survival Rate | survival rate free of liver transplantation within 1 year after enrollment | 1 year | 
| Incidence of Stent Dysfunction | Narrowing or even complete occlusion of the stent, evidenced by imaging examination and/or upper gastrointestinal endoscopy, with or without clinic symptoms. | 1 year | 
| Incidence of Portal Hypertension Related Severe Complications | Incidence of severe complications of portal hypertension, especially for failure of control of acute variceal bleeding and clinical significant rebleeding. | 1 year | 
| Change of Nutritional Status | Human body components analysis, evaluated by score of the Inbody Test. | 1 year | 
| Change of Quality of Life | Health related quality of life, assessed by score of the widely used questionaire Short Form 36. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatic Encephalopathy, Diet Management, Transjugular Intrahepatic Portosystemic Shunt