Portal Hypertension
Conditions
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.
Interventions
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Cirrhosis 2. Patients who had bled from esophageal varices (≥5days and ≤28days) 3. Child-Pugh B or Child-Pugh C≤13
Exclusion criteria
1. THE presence of gastric varices 2. Non-cirrhotic portal hypertension 3. Portal vein thrombosis 4. The history of hepatic encephalopathy 5. Total bilirubin ≥51.3 umol/L 6. Previous treatment of TIPS or surgery 7. Proven malignancy including hepatocellular carcinoma 8. Contraindications to TIPS、EVL or propranolol 9. End-stage renal disease under renal replacement therapy; 10. Cardiorespiratory failure 11. Pregnancy or patients not giving informed consent for endoscopic procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variceal rebleeding rate | 3 years | Analysis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with improving or worsening hepatic function | 3 years | Analysis |
| TIPS dysfunction rate | 3 years | Analysis |
| Hepatic encephalopathy rate | 3 years | Analysis |
| Number of participants with improving or worsening quality of life | 3 years | Analysis |
| Mortality rate | 3 years | Analysis |
| The incidence of complications | 3 years | Analysis |
Countries
China
Outcome results
None listed