A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
NCT ID: NCT00799851
Last Updated: 2008-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
38 participants
INTERVENTIONAL
2004-11-30
2007-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Variceal band ligation
VBL was performed with a multiband ligation device (Euroligator System®). The first band was placed at or close to the gastroesophageal junction, with subsequent bands being placed proximally in a slightly spiral pattern. All visible varices within the distal esophagus were treated, with a maximum of 10 bands being placed in each session. There was a 3-week interval between each treatment session. When VBL was technically impossible due to scarring, sclerotherapy with ethanolamine oleate was performed on thin vessels.
Variceal band ligation
cyanoacrylate injection
CI group received intravariceal injections of 0.5 ml of N-butyl-2-cyanoacrylate (Histoacryl®) diluted in 0.5 ml of Lipiodol (Lipiodol®). Before injection of the Histoacryl-Lipiodol mixture, the catheter was filled up with 1 ml of Lipiodol. After puncturing the EV, the mixture was injected inside it and followed by injection of 1 ml of distilled water. Finally the catheter was retracted. To minimize the risk of embolism, a maximum of two medium or large vessels, in opposite walls, were treated in each session and not more than 0.5 ml of Histoacryl® was injected into each vessel.
A second injection was performed in any EV that maintained blood flow (medium or large size, blue, depressive at palpation with the catheter), in a bi-weekly interval basis. A chest x-ray was performed to evaluate the location of the Histoacryl-Lipiodol solution. Small vessels were treated with ethanolamine oleate sclerotherapy.
cyanoacrylate injection
cyanoacrylate injection
Interventions
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Variceal band ligation
cyanoacrylate injection
cyanoacrylate injection
Eligibility Criteria
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Inclusion Criteria
* medium and/or large esophageal varices
Exclusion Criteria
* history of shunt operation
18 Years
80 Years
ALL
No
Sponsors
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Federal University of São Paulo
OTHER
Locations
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Federal University Of São Paulo - Gastroenterology
São Paulo, São Paulo, Brazil
Countries
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Other Identifiers
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1244/04
Identifier Type: -
Identifier Source: org_study_id