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

Not Applicable

• Conditions: Hepatic Encephalopathy
• Interventions: Dietary Supplement: diet management strategy for encephalopathy

• Registration Number: NCT03372499
• Lead Sponsor: Li Yang

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.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-08
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-08
• Last Update Submitted: 2017-12-08
• Study First Posted: 2017-12-13
• Last Update Posted: 2017-12-13
• Primary Completion: 2018-11
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
nutritional management group	diet management strategy for encephalopathy	diet management strategy for encephalopathy

Primary Outcome Measures

Name	Time	Method
Incidence of Hepatic Encephalopathy	1 year	incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment

Secondary Outcome Measures

Name	Time	Method
Liver Transplantation-free Survival Rate	1 year	survival rate free of liver transplantation within 1 year after enrollment
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.
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.

Trial Locations

Locations (1)

West China Hospital, Sichuan University; 🇨🇳 Chengdu, Sichuan, China