The Influence of Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy

Study Overview
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Brief Summary
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Through a multicenter randomized controlled trial of TIPS to prevent post-hepatitis B cirrhosis of esophagogastric varices, the incidence of hepatic encephalopathy, the rate of stent patency, the incidence of rebleeding and survival in the left and right branches of the portal vein were compared.

Detailed Description
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The most common cause of cirrhosis in China is hepatitis B virus infection; post-hepatitis B cirrhosis with gastroesophageal variceal hemorrhage is common in clinical practice; recent studies [14] found that implantation of 8 mm diameter is compared with the use of 10 mm diameter stents. The membrane stent significantly reduced the incidence of HE after TIPS without affecting the shunt effect. To further evaluate the effect of left/right branch of shunt portal on hepatic encephalopathy after TIPS, we intend to conduct the following studies: for individual etiology (post-hepatitis B cirrhosis), the only indication (to prevent recurrent rupture of gastroesophageal varices) ), implanted 8mm diameter Viatorr stent, unified HE evaluation criteria, and stratified multi-center randomized clinical trial study with Child classification, hope to guide TIPS in line with China's national conditions through the high-level evidence-based medical evidence obtained.

Official Title
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The Influence of Shunting Left/Right Portal Vein Branch on Post-transjugular Intrahepatic Portosystemic Shunt Hepatic Encephalopathy: a Multicenter Randomized Controlled Trial

Conditions
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Portal Hypertension, Hepatic Encephalopathy

Intervention / Treatment
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* Procedure: trans jugular intrahepatic portal systemic shunt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The patient's gender is not limited, ≥ 18 years old and ≤ 75 years old; Clinically diagnosed post-hepatitis B cirrhosis; History of esophageal varices venous rupture confirmed by endoscopy, re-bleeding after standard treatment; Liver function Child A or B; Imaging (CT or MRI) suggests that the left/right first branch of the intrahepatic portal can construct a shunt; Platelet count ≥ 50 × 109 / L; Prothrombin time (PT) does not exceed the upper limit of the normal control for 3 seconds; Serum creatinine concentration ≤115umol/L; Patients and their families agree to join the clinical trial and sign an informed consent form. Exclusion Criteria: Imaging confirms portal vein thrombosis; Patients who have undergone previous surgical treatment of portal hypertension (including splenectomy, surgical disconnection or shunt); Combine any malignant tumor; History of previous hepatic encephalopathy; Consolidation of intractable ascites; Pulmonary artery pressure > 40 mmHg, left ventricular ejection fraction < 50%, congestive heart failure or severe valvular insufficiency; Others: persistent active bleeding, vital signs can not be maintained, blood ammonia ≥ 100, total bilirubin > 51umol / L failed to improve after symptomatic treatment; combined active infection, especially biliary system inflammation; female patients are pregnant Or lactation; severe contrast allergy.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Left Portal Vein Branch<br>Shunt left portal vein branch during the trans jugular intrahepatic portal systemic shunt | Procedure: trans jugular intrahepatic portal systemic shunt<br>* Shunting left or right PV branch in the TIPS procedure<br>|
| Experimental: Right Portal Vein Branch<br>Shunt right portal vein branch during the trans jugular intrahepatic portal systemic shunt | Procedure: trans jugular intrahepatic portal systemic shunt<br>* Shunting left or right PV branch in the TIPS procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of HE | compare difference incidence of HE between shunting left and right portal vein branch | 2 years |