8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding

Study Overview
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Brief Summary
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The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm expanded polytetrafluoroethylene(ePTFE)-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Detailed Description
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For the prevention of recurrent esophageal variceal bleeding, previous clinical studies and meta-analysis show that patients treated with transjugular intrahepatic portosystemic shunt (TIPS) have lower rebleeding rates compared with endoscopic therapy. However, TIPS is associated with higher rates of portosystemic encephalopathy and does not show survival benefit. TIPS with a small-diameter may achieve sufficient portal decompression and reduce the incidence of hepatic encephalopathy. The aim of this study was to conduct a prospective randomized trial to compare TIPS with 8mm ePTFE-covered stents and endoscopic variceal ligation plus propranolol for the prevention of recurrent esophageal variceal bleeding.

Official Title
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Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding

Conditions
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Portal Hypertension

Intervention / Treatment
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* Procedure: 8mm-TIPS
* Procedure: Endoscopic variceal ligation
* Drug: Propranolol
* Device: 8mm ePTFE-covered stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh B or Child-Pugh C≤13 Exclusion Criteria: THE presence of gastric varices Non-cirrhotic portal hypertension Portal vein thrombosis The history of hepatic encephalopathy Total bilirubin ≥51.3 umol/L Previous treatment of TIPS or surgery Proven malignancy including hepatocellular carcinoma Contraindications to TIPS、EVL or propranolol End-stage renal disease under renal replacement therapy; Cardiorespiratory failure Pregnancy or patients not giving informed consent for endoscopic procedures

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 8mm-TIPS<br>Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. | Procedure: 8mm-TIPS<br> <br> Device: 8mm ePTFE-covered stent<br> <br> |
| Active Comparator: EVL plus propranolol<br>Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. | Procedure: Endoscopic variceal ligation<br> <br> Drug: Propranolol<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal rebleeding rate | Analysis | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatic encephalopathy rate | Analysis | 3 years | 
| Number of participants with improving or worsening hepatic function | Analysis | 3 years | 
| TIPS dysfunction rate | Analysis | 3 years | 
| The incidence of complications | Analysis | 3 years | 
| Number of participants with improving or worsening quality of life | Analysis | 3 years | 
| Mortality rate | Analysis | 3 years |