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

Not Applicable

• Conditions: Esophageal Varices in Cirrhosis of the Liver
• Interventions: Procedure: Routing Therapy; Procedure: HVPG-guided therapy

• Registration Number: NCT03687216
• Lead Sponsor: West China Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-09-20
• Study First Posted: 2018-09-27
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-11
• Last Update Posted: 2019-03-13
• Study Start: 2019-09
• Primary Completion: 2020-09
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routing group	Routing Therapy	Routing therapy (EVL plus NSBB)
HVPG group	HVPG-guided therapy	HVPG-guided therapy (TIPS or EVL plus NSBB according to HVPG)

Primary Outcome Measures

Name	Time	Method
Variceal rebleeding rate	One year of follow-up	The incidence of clinically significant gastrointestinal variceal bleeding

Secondary Outcome Measures

Name	Time	Method
Liver transplant-free survivial	One year of follow-up	Time from the procedure to the date of lost-to-follow-up or death or liver transplant
Hepatic encephalopathy: The incidence of hepatic encephalopathy	One year of follow-up	The incidence of hepatic encephalopathy
Cirrhotic complications	One year of follow-up	portal vein thrombosis, liver dysfunction, hepatorenal syndrome et al.
Ascites: The incidence of ascites detected by ultrasound	One year of follow-up	The incidence of ascites detected by ultrasound

Trial Locations

Locations (1)

West China Hospital; 🇨🇳 Chengdu, Sichuan, China