Comparison of Endoscopic Injection of Conventional and Double Doses Cyanoacrylate for Gastric Variceal Hemorrhage
1 other identifier
interventional
105
0 countries
N/A
Brief Summary
The recent practice guideline recommends endoscopic injection of cyanoacrylate (GVO) is the preferred method to treat acute gastric variceal bleeding. The rebleeding rate remains high following GVO.We hypothesized that a double-dose of cyanoacrylate may obliterate the varices more effectively and achieve better hemostasis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Sep 2005
Typical duration for phase_4
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
Study Start
First participant enrolled
September 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 12, 2008
CompletedFirst Posted
Study publicly available on registry
August 14, 2008
CompletedOctober 6, 2010
August 1, 2008
1.9 years
August 12, 2008
October 4, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rebleeding
2 year
Secondary Outcomes (1)
Survival
2 year
Study Arms (2)
A
ACTIVE COMPARATORSingle dose cyanoacrylate in one shot
B
EXPERIMENTALDouble doses cyanoacrylate in one shot
Interventions
Eligibility Criteria
You may qualify if:
- Patients with liver cirrhosis and/or hepatoma
- Aged 18 to 80, who had endoscopy-proven acute GVB
- Clinical signs of hematemesis, coffee ground vomitus, hematochezia, or melena
- Endoscopic signs of active bleeding from the GV
- Adherent blood clots, white nipple signs, or erosions on the GV
- The presence of distinct large GV with red-color signs and absence of EV and other bleeding sources
- Who or their legally authorized representatives gave informed consent
You may not qualify if:
- Patients had previous endoscopic, surgical treatment or transjugular intrahepatic portosystemic shunt (TIPS) for GVB
- Had a terminal illness of any major organ system, such as heart failure, uremia, chronic pulmonary disease, or non-hepatic malignancy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hou MC, Lin HC, Lee HS, Liao WC, Lee FY, Lee SD. A randomized trial of endoscopic cyanoacrylate injection for acute gastric variceal bleeding: 0.5 mL versus 1.0 mL. Gastrointest Endosc. 2009 Oct;70(4):668-75. doi: 10.1016/j.gie.2009.02.005. Epub 2009 Jun 25.
PMID: 19559427DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
Study Record Dates
First Submitted
August 12, 2008
First Posted
August 14, 2008
Study Start
September 1, 2005
Primary Completion
August 1, 2007
Study Completion
October 1, 2007
Last Updated
October 6, 2010
Record last verified: 2008-08