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

NCT00799851 | Completed Phase 4 DMC

• 1 other identifier: 1244/04
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Disease

Keywords

advanced liver disease; esophageal varices; band ligation; cyanoacrylate injection

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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 Finally the catheter was retracted.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.

Drug: cyanoacrylate injection

Interventions

Variceal band ligation DEVICE

Variceal band ligation

cyanoacrylate injection DRUG

cyanoacrylate injection

cyanoacrylate injection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• advanced liver disease (Child-Pugh ≥ 8 points)
• medium and/or large esophageal varices

You may not qualify if:

• prior endoscopic treatment.
• history of shunt operation

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University Of São Paulo - Gastroenterology

São Paulo, São Paulo, 04081000, Brazil

Location

MeSH Terms

Conditions

Liver Diseases; Esophageal and Gastric Varices

Interventions

Cyanoacrylates

Condition Hierarchy (Ancestors)

Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Hypertension, Portal

Intervention Hierarchy (Ancestors)

Acrylates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Nitriles; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Tissue Adhesives; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2004
• Primary Completion: May 1, 2007
• Study Completion: August 1, 2007
• Last Updated: December 1, 2008

Record last verified: 2008-11

Locations

BR (1)