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

Arm | Intervention/treatment |
---|---|
Experimental: nutritional management group
diet management strategy for encephalopathy
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Dietary Supplement: diet management strategy for encephalopathy
diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
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No Intervention: control group
Current ordinary guidance for patients after TIPS placement performed by trained nurse in the inpatient department
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- Incidence of Hepatic Encephalopathy [ Time Frame: 1 year ]incidence of symptomatic hepatic encephalopathy in all stages within 1 year after enrollment
- Liver Transplantation-free Survival Rate [ Time Frame: 1 year ]survival rate free of liver transplantation within 1 year after enrollment
- 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.
- 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.
- Change of Nutritional Status [ Time Frame: 1 year ]Human body components analysis, evaluated by score of the Inbody Test.
- 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.

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

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
Contact: Li Yang, MD | +86 18980601276 | yangli_hx@scu.edu.cn | |
Contact: Yongjun Zhu, Doctor | +86 13281121937 | hp545204493@126.com |
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 |
Study Director: | Li Yang, MD | Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University |
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 |