Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation (DM-PTHE)

Li Yang

Status: Unknown

Conditions: Hepatic Encephalopathy

Treatments: Dietary Supplement: diet management strategy for encephalopathy

Study type: Interventional

Funder types: Other

Identifiers

NCT03372499

DM-PTHE

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

nutritional management group

Experimental group

Description:

diet management strategy for encephalopathy

Treatment:

Dietary Supplement: diet management strategy for encephalopathy

control group

No Intervention group

Description:

Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department