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NCT00799851 Clinical Trial

A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices

Liver Disease Clinical Trial

Official title:
Endoscopic Treatment of Esophageal Varices in Advanced Liver Disease Patients: a Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00799851
Other study ID # 1244/04
Secondary ID
Status Completed
Phase Phase 4
First received November 28, 2008
Last updated November 28, 2008
Start date November 2004
Est. completion date August 2007

Study information
Verified date November 2008
Source Federal University of São Paulo
Contact n/a
Is FDA regulated No
Health authority Brazil: National Committee of Ethics in ResearchUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced liver disease regarding eradication, bleeding, mortality, complication and recurrence rates.

Recruitment information / eligibility
Status Completed
Enrollment 38
Est. completion date August 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- advanced liver disease (Child-Pugh = 8 points)

- medium and/or large esophageal varices

Exclusion Criteria:

- prior endoscopic treatment.

- history of shunt operation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• Variceal band ligation

Drug:
• cyanoacrylate injection
cyanoacrylate injection

Locations
Country Name City State
Brazil Federal University Of São Paulo - Gastroenterology São Paulo

Sponsors (1)
Lead Sponsor Collaborator
Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Compare VBL and cyanoacrylate injection (CI) in the treatment of EV in patients with advanced liver disease regarding eradication, bleeding, mortality, complication and recurrence rates. Yes
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