HVPG-Guided Therapy Versus EVL Plus NSBB in Second Prophylaxis of Esophageal Variceal Bleeding

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center Randomized Controlled Study of Secondary Prophylaxis of Cirrhosis Related Esophagogastric Variceal Hemorrhage Treated With HVPG-guided Therapy or Standard Esophageal Variceal Ligation Plus Beta-blocker

Conditions
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Esophageal Varices in Cirrhosis of the Liver

Intervention / Treatment
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* Procedure: HVPG-guided therapy
* Procedure: Routing Therapy


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HVPG group<br>HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG) | Procedure: HVPG-guided therapy<br>* 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.<br>|
| Active Comparator: Routing group<br>Routing therapy (EVL plus NSBB) | Procedure: Routing Therapy<br>* Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variceal rebleeding rate | The incidence of clinically significant gastrointestinal variceal bleeding | One year of follow-up | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |