Using Covered Stent of Diameter of 7mm in TIPS

Study Overview
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Brief Summary
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This study evaluates the incidence of hepatic encephalopathy between covered stent of diameter of 7mm and 8mm in TIPS(transjugular intrahepatic portosystemic stent shunt ).Half of the participants will receive stent of diameter of 7mm ,while the other half will receive stent of diameter of 8mm.

Detailed Description
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TIPS is effective in the treatment of hemorrhage of digestive tract and intractable ascites,which are the complications of cirrhosis. At present, the high incidence of hepatic encephalopathy has been a major problem after TIPS. The high incidence rate of hepatic encephalopathy was closly associated with the diameter of the stent. We often use the stent of diameter 8mm in TIPS.In this study, we try to use the stent of smaller diameter of 7mm in TIPS,and compare the incidence of hepatic encephalopathy between the stent of diameter of 7mm and 8mm .

Official Title
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Using Covered Stent of Diameter of 7mm in a Prospective, Single Blind, Randomized, Controlled Study of TIPS(Transjugular Intrahepatic Portosystemic Stent Shunt )

Conditions
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Liver Disease

Intervention / Treatment
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* Device: the stent of diameter of 7mm
* Device: the stent of diameter of 8mm


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: there is a clear TIPS treatment indications of liver cirrhosis portal hypertension patients of gastrointestinal bleeding. undergoing elective TIPS to treat patients. aged 18-70 years old Exclusion Criteria: preoperative patients with hepatic encephalopathy. with portal vein thrombosis patients. combined liver malignant tumor or other parts of the patients with malignant tumor. In combination of peptic ulcer bleeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: the stent of diameter of 7mm<br>Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,7mm balloon,Pigtail catheter,the stent of diameter of 7mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No | Device: the stent of diameter of 7mm<br>* 108 patients use the stent of diameter of 7mm in TIPS<br>|
| Other: the stent of diameter of 8mm<br>Procedure/Surgery:Jugular vein puncture and catheterization. Device:RUPS-100(COOK Company)sheath ,8mm balloon,Pigtail catheter,the stent of diameter of 8mm (Bard,Fluency) Drug(including placebo):No Biological/Vaccine:No | Device: the stent of diameter of 8mm<br>* 108 patients use the stent of diameter of 8mm in TIPS<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of hepatic encephalopathy after TIPS | The incidence of hepatic encephalopathy after TIPS in 7day,1,3,6,12month | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of shunt restenosis after TIPS | The incidence of shunt restenosis after TIPS in 7day,1,3,6,12month | 1 year | 
| the recurrence rate of gastrointestinal bleeding after TIPS | The recurrence rate of gastrointestinal bleeding after TIPS in 7day,1,3,6,12month | 1 year | 
| Portal venous pressure before and afterTIPS | Portal venous pressure before and afterTIPS. | 1 year | 
| liver function in different periods | liver function during different periods before and after TIPS in 7day,1,3,6,12month | 1 year | 
| blood ammonia in different periods | blood ammonia before and after TIPS in 7day,1,3,6,12month | 1 year | 
| jaundice index in different periods | jaundice index before and after TIPS in 7day,1,3,6,12month | 1 year | 
| platelet count in different periods | platelet count before and after TIPS in 7day,1,3,6,12month | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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transjugular intrahepatic portosystemic shunt