NCT00567216

Brief Summary

Gastric variceal bleeding has a very high rebleeding rate even after endoscopic variceal injection of cyanoacrylate (GVO) which is considered the first choice of endoscopic treatment. Beta-blocker (BB) is effective to lower portal pressure. We hypothesized combination of GVO and BB can further decrease the rebleeding rate.

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 2007

Typical duration 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, 2007

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 4, 2007

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

June 8, 2010

Status Verified

June 1, 2010

First QC Date

December 2, 2007

Last Update Submit

June 6, 2010

Conditions

Liver Cirrhosis and Hepatoma.Gastric Variceal Bleeding

Outcome Measures

Primary Outcomes (1)

  • Rebleeding

    3 yr

Secondary Outcomes (1)

  • Complication Survival

    3 yr

Study Arms (2)

G

NO INTERVENTION

Endoscopic injection of cyanoacrylate alone

C

ACTIVE COMPARATOR

Combination of GVO and nadolol

Drug: Nadolol

Interventions

NadololDRUG

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

C

Eligibility Criteria

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

You may qualify if:

  • clinical diagnosis of liver cirrhosis and/or HCC, endoscopically proven gastric variceal bleeding

You may not qualify if:

  • younger than 18 y/o or older than 80 y/o, terminal illness, other major systemic disease or malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Veteran General Hospital-Taipei

Taipei City, Taiwan, 11217, China

RECRUITING

MeSH Terms

Conditions

Liver CirrhosisCarcinoma, Hepatocellular

Interventions

Nadolol

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesFibrosisPathologic ProcessesPathological Conditions, Signs and SymptomsAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by Site

Intervention Hierarchy (Ancestors)

PhenoxypropanolaminesPropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAmines

Study Officials

  • Ming-Chih Hou, MD

    Taipei Veterans General Hospital, Taiwan

    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
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

December 2, 2007

First Posted

December 4, 2007

Study Start

April 1, 2007

Study Completion

July 1, 2010

Last Updated

June 8, 2010

Record last verified: 2010-06

Locations

CN(1)