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

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

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 Overview

• Status: Unknown
• Conditions: Esophageal Varices in Cirrhosis of the Liver
• Intervention / Treatment: Procedure: HVPG-guided therapy; Procedure: Routing Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China, 610041
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 20, 2018
• First Posted (Actual): September 27, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2019
• Last Update Submitted That Met QC Criteria: March 11, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Gastrointestinal Diseases; Liver Diseases; Esophageal Diseases; Hypertension, Portal; Fibrosis; Liver Cirrhosis; Esophageal and Gastric Varices
• Other Study ID Numbers: HGT-EN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No