8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
- Conditions
- Portal Hypertension
- Interventions
- Registration Number
- NCT03094234
- Lead Sponsor
- West China Hospital
- 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 in patients with Child A cirrhosis
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 72
Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -
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 procedure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 8mm-TIPS 8mm-TIPS Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents. EVL plus propranolol endoscopic variceal ligation (EVL) Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment. EVL plus propranolol Propranolol Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
- Primary Outcome Measures
Name Time Method Variceal rebleeding rate 3 years Analysis
- Secondary Outcome Measures
Name Time Method Hepatic encephalopathy rate 3 years Analysis
TIPS dysfunction rate 3 years Analysis
The incidence of complications 3 years Analysis
Mortality rate 3 years Analysis
Trial Locations
- Locations (1)
West china hospital
🇨🇳Chengdu, China