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
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|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|
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
- 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.
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 firstname.lastname@example.org|
|Contact: Yongjun Zhu, Doctor||+86 email@example.com|
|West China Hospital, Sichuan University||Recruiting|
|Chengdu, Sichuan, China, +86|
|Contact: Li Yang, MD +86 18980601276 firstname.lastname@example.org|
|Contact: Yongjun Zhu, Doctor +86 13281121937 email@example.com|
|Principal Investigator: Yongjun Zhu, Doctor|
|Study Director:||Li Yang, MD||Department of Gastroenterology and Hepatology, West China Hospital, Sichuan University|