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
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- West China Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Variceal rebleeding rate
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
HVPG group
HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)
Intervention: HVPG-guided therapy (Procedure)
Routing group
Routing therapy (EVL plus NSBB)
Intervention: Routing Therapy (Procedure)
Outcomes
Primary Outcomes
Variceal rebleeding rate
Time Frame: One year of follow-up
The incidence of clinically significant gastrointestinal variceal bleeding
Secondary Outcomes
- Liver transplant-free survivial(One year of follow-up)
- Hepatic encephalopathy: The incidence of hepatic encephalopathy(One year of follow-up)
- Cirrhotic complications(One year of follow-up)
- Ascites: The incidence of ascites detected by ultrasound(One year of follow-up)
Investigators
Li Yang
Director of Department of Gastroenterology and Hepatology
West China Hospital