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

December 8, 2017 updated by: Li Yang

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

86

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Sichuan
      • Chengdu, Sichuan, China, +86
        • Recruiting
        • West China Hospital, Sichuan University
        • Contact:
        • Principal Investigator:
          • Yongjun Zhu, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: nutritional management group
diet management strategy for encephalopathy
Dietary supplement: diet management strategy for encephalopathy
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
NO_INTERVENTION: control group
Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hepatic Encephalopathy
Time Frame: 1 year
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
Time Frame: 1 year
survival rate free of liver transplantation within 1 year after enrollment
1 year
Incidence of Stent Dysfunction
Time Frame: 1 year
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
Time Frame: 1 year
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
Time Frame: 1 year
Human body components analysis, evaluated by score of the Inbody Test.
1 year
Change of Quality of Life
Time Frame: 1 year
Health related quality of life, assessed by score of the widely used questionaire Short Form 36.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Li Yang

Collaborators

West China Hospital

Investigators

  • Study Director: Li Yang, MD, Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2017

Primary Completion (ANTICIPATED)

November 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

November 8, 2017

First Submitted That Met QC Criteria

December 8, 2017

First Posted (ACTUAL)

December 13, 2017

Study Record Updates

Last Update Posted (ACTUAL)

December 13, 2017

Last Update Submitted That Met QC Criteria

December 8, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DM-PTHE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The investigators need to discuss with other participants whether or not to share data of the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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