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

Primary Purpose

Hepatic Encephalopathy

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
diet management strategy for encephalopathy
Sponsored by
Li Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Diet Management, Transjugular Intrahepatic Portosystemic Shunt

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • West China Hospital, Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

nutritional management group

control group

Arm Description

diet management strategy for encephalopathy

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Liver Transplantation-free Survival Rate
survival rate free of liver transplantation within 1 year after enrollment
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.
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.
Change of Nutritional Status
Human body components analysis, evaluated by score of the Inbody Test.
Change of Quality of Life
Health related quality of life, assessed by score of the widely used questionaire Short Form 36.

Full Information

First Posted
November 8, 2017
Last Updated
December 8, 2017
Sponsor
Li Yang
Collaborators
West China Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03372499
Brief Title
Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation
Acronym
DM-PTHE
Official Title
Effect of Diet Management on Incidence of Hepatic Encephalopathy of Patients With Cirrhosis and Variceal Bleeding After Transjugular Intrahepatic Portosystemic Shunt Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Yang
Collaborators
West China Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic Encephalopathy, Diet Management, Transjugular Intrahepatic Portosystemic Shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
nutritional management group
Arm Type
Experimental
Arm Description
diet management strategy for encephalopathy
Arm Title
control group
Arm Type
No Intervention
Arm Description
Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department
Intervention Type
Dietary Supplement
Intervention Name(s)
diet management strategy for encephalopathy
Intervention Description
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
Primary Outcome Measure Information:
Title
Incidence of Hepatic Encephalopathy
Description
incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Liver Transplantation-free Survival Rate
Description
survival rate free of liver transplantation within 1 year after enrollment
Time Frame
1 year
Title
Incidence of Stent Dysfunction
Description
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
Title
Incidence of Portal Hypertension Related Severe Complications
Description
Incidence of severe complications of portal hypertension, especially for failure of control of acute variceal bleeding and clinical significant rebleeding.
Time Frame
1 year
Title
Change of Nutritional Status
Description
Human body components analysis, evaluated by score of the Inbody Test.
Time Frame
1 year
Title
Change of Quality of Life
Description
Health related quality of life, assessed by score of the widely used questionaire Short Form 36.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Yang, MD
Phone
+86 18980601276
Email
yangli_hx@scu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Yongjun Zhu, Doctor
Phone
+86 13281121937
Email
hp545204493@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Organizational Affiliation
Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University
Official's Role
Study Director
Facility Information:
Facility Name
West China Hospital, Sichuan University
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
+86
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Yang, MD
Phone
+86 18980601276
Email
yangli_hx@scu.edu.cn
First Name & Middle Initial & Last Name & Degree
Yongjun Zhu, Doctor
Phone
+86 13281121937
Email
hp545204493@126.com
First Name & Middle Initial & Last Name & Degree
Yongjun Zhu, Doctor

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
The investigators need to discuss with other participants whether or not to share data of the study.
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Diet Management on Hepatic Encephalopathy of Patients With Variceal Bleeding After Intrahepatic Portosystemic Shunt Creation

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