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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
86
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
RECRUITINGIncidence of Hepatic Encephalopathy
incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment
Time frame: 1 year
Liver Transplantation-free Survival Rate
survival rate free of liver transplantation within 1 year after enrollment
Time frame: 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.
Time frame: 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.
Time frame: 1 year
Change of Nutritional Status
Human body components analysis, evaluated by score of the Inbody Test.
Time frame: 1 year
Change of Quality of Life
Health related quality of life, assessed by score of the widely used questionaire Short Form 36.
Time frame: 1 year
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