NCT03171805

Brief Summary

Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.

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
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 31, 2017

Completed
1 day until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

5 years

First QC Date

May 26, 2017

Last Update Submit

November 20, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Worsening of esophageal varices rate

    Analysis

    3 years

Secondary Outcomes (3)

  • Variceal rebleeding rate

    3 years

  • Mortality rate

    3 years

  • Worsening of ascites rate

    3 years

Study Arms (2)

Propranolol group

EXPERIMENTAL

Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.

Drug: Propranolol

control group

NO INTERVENTION

Propranolol was not given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.

Interventions

Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.

Propranolol group

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of liver cirrhosis
  • Clinical diagnosis of isolated gastric varices
  • The presenec of spontaneous portosystemic shunt

You may not qualify if:

  • Contradictions to Propranolol
  • Balloon occluded retrograde transvenous obliteration was failed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West china Hospital

Chengdu, China

RECRUITING

MeSH Terms

Conditions

Hypertension, PortalEsophageal and Gastric Varices

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesEsophageal DiseasesGastrointestinal Diseases

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • xuefeng luo

    Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending doctor

Study Record Dates

First Submitted

May 26, 2017

First Posted

May 31, 2017

Study Start

June 1, 2017

Primary Completion

May 15, 2022

Study Completion

December 30, 2022

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations