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Sponsored by: |
Federal University of São Paulo |
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Information provided by: | Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00799851 |
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.
Condition | Intervention | Phase |
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Liver Disease |
Device: Variceal band ligation Drug: cyanoacrylate injection |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Endoscopic Treatment of Esophageal Varices in Advanced Liver Disease Patients: a Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection |
Enrollment: | 38 |
Study Start Date: | November 2004 |
Study Completion Date: | August 2007 |
Primary Completion Date: | May 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Variceal band ligation: Active Comparator
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. |
Device: Variceal band ligation |
cyanoacrylate injection: Active Comparator
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 Finally the catheter was retracted.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.
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Drug: cyanoacrylate injection
cyanoacrylate injection
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study ID Numbers: | 1244/04 |
Study First Received: | November 28, 2008 |
Last Updated: | November 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00799851 History of Changes |
Health Authority: | Brazil: National Committee of Ethics in Research; United States: Food and Drug Administration |
advanced liver disease esophageal varices band ligation cyanoacrylate injection |
Liver Diseases Digestive System Diseases Varicose Veins Esophageal Disorder Gastrointestinal Diseases Portal Hypertension |
Vascular Diseases Esophageal and Gastric Varices Hypertension, Portal Esophageal Diseases Esophageal Varices Hypertension |
Liver Diseases Digestive System Diseases Varicose Veins Gastrointestinal Diseases Vascular Diseases |
Esophageal and Gastric Varices Cardiovascular Diseases Hypertension, Portal Esophageal Diseases |