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

Sichuan University

Status: Unknown

Conditions: Esophageal Varices in Cirrhosis of the Liver

Treatments: Procedure: HVPG-guided therapy; Procedure: Routing Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03687216

HGT-EN

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

HVPG group

Experimental group

Description:

HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)

Treatment:

Procedure: HVPG-guided therapy

Routing group

Active Comparator group

Description:

Routing therapy (EVL plus NSBB)

Treatment:

Procedure: Routing Therapy