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Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

NCT02115061 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2014-04-15

No results posted yet for this study

Summary

The purpose of the spring is to maintain the cyanoacrylate polymer of the gastric varix, forming a conglomerate spring-cyanoacrylate, and thus preventing their migration to the adhesive embolism.

The introduction of the spring is held by a echo-guided puncture. The window can be puncture through the distal esophagus or directly in the gastric varix via retroflexion to the fundus. Another advantage of this technique is its use in the presence of bleeding, when large amounts of blood in the stomach hinders the injection of the cyanoacrylate, by pricking the distal esophagus that difficulty decreases. The first study of this technique was performed by Binmoeller et al (21) and had good results with 100% hemostasis and low rebleeding rate (16%), but more studies are needed to prove the safety and efficacy of this technique.

Conditions

  • Gastric Varices

Interventions

DEVICE

Treatment: coil + cyanoacrylate

This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.

DEVICE

Treatment: cyanoacrylate

This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Maíra R de Almeida · Hospital das Clínicas da FMUSP

  • Dalton Chaves · Hospital das Clínicas FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-08-31
Completion
2014-10-31

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02115061 on ClinicalTrials.gov