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

West China Hospital160 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

160

Conditions

Esophageal Varices in Cirrhosis of the Liver

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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;