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

Phase 4

Completed

• Conditions: Liver Disease
• Interventions: Device: Variceal band ligation; Drug: cyanoacrylate injection

• Registration Number: NCT00799851
• Lead Sponsor: Federal University of São Paulo

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2007-05
• Study Completion: 2007-08
• Status Verified: 2008-11
• Study First Submitted: 2008-11-28
• Study First Submitted QC: 2008-11-28
• Last Update Submitted: 2008-11-28
• Study First Posted: 2008-12-01
• Last Update Posted: 2008-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Variceal band ligation	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.
cyanoacrylate injection	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 Finally the catheter was retracted.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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Federal University Of São Paulo - Gastroenterology; 🇧🇷 São Paulo, Brazil