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

NCT03687216 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2019-03-13

No results posted yet for this study

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.

Conditions

  • Esophageal Varices in Cirrhosis of the Liver

Interventions

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.

PROCEDURE

Routing Therapy

Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.

Sponsors & Collaborators

  • West China Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-30
Primary Completion
2020-09-30
Completion
2020-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687216 on ClinicalTrials.gov