Esophageal Varices in Cirrhosis of the Liver
Conditions
Brief summary
A single-center randomized controlled study comparing endoscopic or interventional therapy guided by the hepatic venous pressure gradient (HVPG) , to standard endosopic variceal ligation plus nonselective beta-blocker therapy (NSBB) in patients with esophageal varices due to liver cirrhosis with a history of esophageal variceal hemorrhage.Primary study outcome of the study is variceal rebleeding episodes occurring within the first years after interventions. Second study outcomes of the study are hepatic encephalopathy occurrence, mortality occurrence, liver transplantation or other cirrhosis-related complications.
Interventions
PROCEDUREHVPG-guided therapy
The baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) . Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails.
PROCEDURERouting Therapy
Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.
Sponsors
West China Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Liver cirrhosis diagnosed by clinical examination, imaging or biopsy; * A previous history of variceal hemorrhage; * Written informed consent.
Exclusion criteria
* Previous history of secondary prophylactic treatment; * Contraindications to treatment of endoscopy, surgery and TIPS * Severe cardiac, pulmonary or renal dysfunction; * Lactating or pregnant; * Malignancies;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variceal rebleeding rate | One year of follow-up | The incidence of clinically significant gastrointestinal variceal bleeding |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic encephalopathy: The incidence of hepatic encephalopathy | One year of follow-up | The incidence of hepatic encephalopathy |
| Ascites: The incidence of ascites detected by ultrasound | One year of follow-up | The incidence of ascites detected by ultrasound |
| Cirrhotic complications | One year of follow-up | portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al. |
| Liver transplant-free survivial | One year of follow-up | Time from the procedure to the date of lost-to-follow-up or death or liver transplant |
Countries
China
Outcome results
None listed