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

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ClinicalTrials.gov Identifier: NCT03372499
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
West China Hospital
Information provided by (Responsible Party):
Li Yang, West China Hospital, Sichuan University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Dietary Supplement: diet management strategy for encephalopathy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Effect of Diet Management on Incidence of Hepatic Encephalopathy of Patients With Cirrhosis and Variceal Bleeding After Transjugular Intrahepatic Portosystemic Shunt Treatment
Actual Study Start Date : October 1, 2017
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : December 2018

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U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Hepatic Encephalopathy [ Time Frame: 1 year ]
    incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment


Secondary Outcome Measures :
  1. Liver Transplantation-free Survival Rate [ Time Frame: 1 year ]
    survival rate free of liver transplantation within 1 year after enrollment

  2. 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.

  3. 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.

  4. Change of Nutritional Status [ Time Frame: 1 year ]
    Human body components analysis, evaluated by score of the Inbody Test.

  5. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372499


Contacts
Contact: Li Yang, MD +86 18980601276 yangli_hx@scu.edu.cn
Contact: Yongjun Zhu, Doctor +86 13281121937 hp545204493@126.com

Locations
China, Sichuan
West China Hospital, Sichuan University Recruiting
Chengdu, Sichuan, China, +86
Contact: Li Yang, MD    +86 18980601276    yangli_hx@scu.edu.cn   
Contact: Yongjun Zhu, Doctor    +86 13281121937    hp545204493@126.com   
Principal Investigator: Yongjun Zhu, Doctor         
Sponsors and Collaborators
Li Yang
West China Hospital
Investigators
Study Director: Li Yang, MD Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Responsible Party: Li Yang, Clinical Professor, West China Hospital, Sichuan University
ClinicalTrials.gov Identifier: NCT03372499     History of Changes
Other Study ID Numbers: DM-PTHE
First Posted: December 13, 2017    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: The investigators need to discuss with other participants whether or not to share data of the study.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Li Yang, West China Hospital, Sichuan University:
Hepatic Encephalopathy
Diet Management
Transjugular Intrahepatic Portosystemic Shunt

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
 Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases