NCT03687216

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 27, 2018

Completed
11 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 13, 2019

Status Verified

March 1, 2019

Enrollment Period

1 year

First QC Date

September 20, 2018

Last Update Submit

March 11, 2019

Conditions

Esophageal Varices in Cirrhosis of the Liver

Outcome Measures

Primary Outcomes (1)

  • Variceal rebleeding rate

    The incidence of clinically significant gastrointestinal variceal bleeding

    One year of follow-up

Secondary Outcomes (4)

  • Hepatic encephalopathy: The incidence of hepatic encephalopathy

    One year of follow-up

  • Ascites: The incidence of ascites detected by ultrasound

    One year of follow-up

  • Cirrhotic complications

    One year of follow-up

  • Liver transplant-free survivial

    One year of follow-up

Study Arms (2)

HVPG group

EXPERIMENTAL

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

Procedure: HVPG-guided therapy

Routing group

ACTIVE COMPARATOR

Routing therapy (EVL plus NSBB)

Procedure: Routing Therapy

Interventions

HVPG-guided therapyPROCEDURE

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.

HVPG group
Routing TherapyPROCEDURE

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

Routing group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Liver cirrhosis diagnosed by clinical examination, imaging or biopsy;
  • A previous history of variceal hemorrhage;
  • Written informed consent.

You may not qualify if:

  • Previous history of secondary prophylactic treatment;
  • Contraindications to treatment of endoscopy, surgery and TIPS
  • Severe cardiac, pulmonary or renal dysfunction;
  • Lactating or pregnant;
  • Malignancies;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West China Hospital

Chengdu, Sichuan, 610041, China

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Department of Gastroenterology and Hepatology

Study Record Dates

First Submitted

September 20, 2018

First Posted

September 27, 2018

Study Start

September 1, 2019

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

March 13, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)