NCT01298271

Brief Summary

Design a randomized trial to compare the effect of endoscopic cyanoacrylate injection obliteration versus non-selective beta-blocker in the primary prevention of gastric variceal bleeding.

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
120

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2010

Longer than P75 for phase_4

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

Study Start

First participant enrolled

April 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 17, 2011

Completed
14.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

September 4, 2019

Status Verified

August 1, 2019

Enrollment Period

15.8 years

First QC Date

October 4, 2010

Last Update Submit

August 29, 2019

Conditions

Bleeding Gastric VaricesLiver Cirrhosis

Keywords

gastric variceal bleedingprimarypreventioncyanoacrylate injectionnon-selective beta-blocker

Outcome Measures

Primary Outcomes (1)

  • Rebleeding

    3 year

Secondary Outcomes (1)

  • complication surivial

    3 year

Study Arms (2)

Cyanoacrylate

NO INTERVENTION

Endoscopic Cyanoacrylate Injection treatment of primary prevention GVB

Propranolol

ACTIVE COMPARATOR

Propranolol is used for primary prevention of GVB

Drug: propranolol

Interventions

propranololDRUG

Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period

Also known as: Inderal, Cardolol
Propranolol

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with live cirrhosis and/or hepatoma
  • Aged 18 to 80, who had endoscopy-Proven EV(-)GV(+)or EV\<GV

You may not qualify if:

  • Patients had previous endoscopic, surgical treatment or Transjugular Intrahepatic Portosystemic Shunt
  • Had a terminal illness of any major organ system,such as heart failure, kindey failure,COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran General Hospital-Taipei

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Propranolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Ming-Chih Hou, MD

    National Yang Ming Chiao Tung University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Chih Hou, MD

CONTACT

886-2-28712111mchou@vghtpe.gov.tw

Han-Chieh Lin, MD

CONTACT

886-2-28712111hclin@vghtpe.gov.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 4, 2010

First Posted

February 17, 2011

Study Start

April 1, 2010

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

September 4, 2019

Record last verified: 2019-08

Locations

TW(1)