8mm-TIPS Versus Endoscopic Variceal Ligation (EVL) Plus Propranolol for Prevention of Variceal Rebleeding in Patients With Child A Cirrhosis
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- West China Hospital
- Enrollment
- 72
- Locations
- 1
- Primary Endpoint
- Variceal rebleeding rate
Study 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Cirrhosis Patients who had bled from esophageal varices (≥5days and ≤28days) Child-Pugh A -
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 procedure
Arms & Interventions
8mm-TIPS
Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
Intervention: 8mm-TIPS (Device)
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Intervention: endoscopic variceal ligation (EVL) (Procedure)
EVL plus propranolol
Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
Intervention: Propranolol (Drug)
Outcomes
Primary Outcomes
Variceal rebleeding rate
Time Frame: 3 years
Analysis
Secondary Outcomes
- Hepatic encephalopathy rate(3 years)
- TIPS dysfunction rate(3 years)
- The incidence of complications(3 years)
- Mortality rate(3 years)
Investigators
luo xuefeng
Principal Investigator
West China Hospital