A Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection for Esophageal Varices
Liver Disease
About this trial
This is an interventional treatment trial for Liver Disease focused on measuring advanced liver disease, esophageal varices, band ligation, cyanoacrylate injection
Eligibility Criteria
Inclusion Criteria:
- advanced liver disease (Child-Pugh ≥ 8 points)
- medium and/or large esophageal varices
Exclusion Criteria:
- prior endoscopic treatment.
- history of shunt operation
Sites / Locations
- Federal University Of São Paulo - Gastroenterology
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Variceal band ligation
cyanoacrylate injection
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.
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 Finally the catheter was retracted.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.