Randomised Trial of 8mm Transjugular Intrahepatic Portosystemic Shunt Versus Endoscopic Variceal Ligation Plus Propranolol for Prevention of Variceal Rebleeding
Overview
- Phase
- Not Applicable
- Intervention
- 8mm-TIPS
- Conditions
- Portal Hypertension
- Sponsor
- West China Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Variceal rebleeding rate
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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
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.
Investigators
luo xuefeng
MD
West China Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Arms & Interventions
8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Intervention: 8mm-TIPS
8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Intervention: 8mm ePTFE-covered stent
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Intervention: Endoscopic variceal ligation
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Intervention: Propranolol
Outcomes
Primary Outcomes
Variceal rebleeding rate
Time Frame: 3 years
Analysis
Secondary Outcomes
- Number of participants with improving or worsening hepatic function(3 years)
- The incidence of complications(3 years)
- Hepatic encephalopathy rate(3 years)
- Number of participants with improving or worsening quality of life(3 years)
- TIPS dysfunction rate(3 years)
- Mortality rate(3 years)