A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
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|ClinicalTrials.gov Identifier: NCT00799851|
Recruitment Status : Completed
First Posted : December 1, 2008
Last Update Posted : December 1, 2008
|Condition or disease||Intervention/treatment||Phase|
|Liver Disease||Device: Variceal band ligation Drug: cyanoacrylate injection||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||38 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Endoscopic Treatment of Esophageal Varices in Advanced Liver Disease Patients: a Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection|
|Study Start Date :||November 2004|
|Actual Primary Completion Date :||May 2007|
|Actual Study Completion Date :||August 2007|
Active Comparator: 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.
Device: Variceal band ligation
Active Comparator: 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 Finally the catheter was retracted.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.
Drug: cyanoacrylate injection
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00799851
|Federal University Of São Paulo - Gastroenterology|
|São Paulo, Brazil, 04081000|