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

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00799851
First received: November 28, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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
Liver Disease
Device: Variceal band ligation
Drug: cyanoacrylate injection
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endoscopic Treatment of Esophageal Varices in Advanced Liver Disease Patients: a Randomized Controlled Trial Comparing Band Ligation and Cyanoacrylate Injection

Resource links provided by NLM:


Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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. [ Designated as safety issue: Yes ]

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
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
cyanoacrylate injection

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00799851

Locations
Brazil
Federal University Of São Paulo - Gastroenterology
São Paulo, Brazil, 04081000
Sponsors and Collaborators
Federal University of São Paulo
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00799851     History of Changes
Other Study ID Numbers: 1244/04
Study First Received: November 28, 2008
Last Updated: November 28, 2008
Health Authority: Brazil: National Committee of Ethics in Research
United States: Food and Drug Administration

Keywords provided by Federal University of São Paulo:
advanced liver disease
esophageal varices
band ligation
cyanoacrylate injection

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014