NCT02115061

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Aug 2013

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 15, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

April 15, 2014

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

April 3, 2014

Last Update Submit

April 11, 2014

Conditions

Gastric Varices

Keywords

Gastric varices,coil,cyanoacrylate,treating gastric varices.

Outcome Measures

Primary Outcomes (1)

  • Compare the results of the treatment of gastric varices, gastric varices treatment coil and cyanocrylate versus cyanocrylate in 28 patients with systemic shunts in relation to efficacy and embolic complications.

    Patient recruitment, the signing of the terms and data collection will be carried out between September 2012 and August 2014. Data analysis and statistical studies between September and October 2014. The scheduled date for completion of the study is the December 2014. The monitoring will be performed with endoscopy and endoscopic ultrasound at 1, 4 and 10 months after the procedure. Analyzed the recurrence and clinical outcome, with completion of new questionnaires.

    Four months after patient recruitment.

Study Arms (2)

Cyanoacrylate

ACTIVE COMPARATOR

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

Device: Treatment: cyanoacrylate

Coil + cyanocrylate

SHAM COMPARATOR

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

Device: Treatment: coil + cyanoacrylate

Interventions

Treatment: coil + cyanoacrylateDEVICE

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

Also known as: Coil + cyanoacrylate
Coil + cyanocrylate
Treatment: cyanoacrylateDEVICE

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

Also known as: Cyanoacrylate
Cyanoacrylate

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with portal hypertension and pseudo-tumor gastric varices type IGV1 or GOV2 and presence of gastrorenal or splenorenal shunt.

You may not qualify if:

  • Refusal of the patient or their legal guardian.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Esophageal and Gastric Varices

Condition Hierarchy (Ancestors)

Esophageal DiseasesGastrointestinal DiseasesDigestive System DiseasesHypertension, PortalLiver Diseases

Study Officials

  • Maíra R de Almeida

    Hospital das Clínicas da FMUSP

    STUDY CHAIR

  • Dalton Chaves

    Hospital das Clínicas FMUSP

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ana C Cândido

CONTACT

55-11-26619577ana.candido@hc.fm.usp.br

Maíra R de Almeida

CONTACT

55-11-26617579mairaralmeida@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2014

First Posted

April 15, 2014

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Study Completion

October 1, 2014

Last Updated

April 15, 2014

Record last verified: 2012-08

Locations

BR(1)