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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HVPG group | Experimental | HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG) |
|
| Routing group | Active Comparator | Routing therapy (EVL plus NSBB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HVPG-guided therapy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Variceal rebleeding rate | The incidence of clinically significant gastrointestinal variceal bleeding | One year of follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic encephalopathy: The incidence of hepatic encephalopathy | The incidence of hepatic encephalopathy | One year of follow-up |
| Ascites: The incidence of ascites detected by ultrasound | The incidence of ascites detected by ultrasound |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | 610041 | China |
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|
| Routing Therapy | Procedure | Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol. |
|
| One year of follow-up |
| Cirrhotic complications | portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al. | One year of follow-up |
| Liver transplant-free survivial | Time from the procedure to the date of lost-to-follow-up or death or liver transplant | One year of follow-up |