ClinicalTrials.gov
ClinicalTrials.gov Menu

Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02115061
Recruitment Status : Unknown
Verified August 2012 by University of Sao Paulo General Hospital.
Recruitment status was:  Recruiting
First Posted : April 15, 2014
Last Update Posted : April 15, 2014
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

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.


Condition or disease Intervention/treatment Phase
Gastric Varices Device: Treatment: coil + cyanoacrylate Device: Treatment: cyanoacrylate Phase 1

Detailed Description:

OBJECTIVE Compare the results of the treatment of gastric varices, coil associated with cianoarilato versus cyanoacrylate in patients with systemic shunts in relation to efficacy and embolic complications.

PATIENTS, MATERIALS AND METHODS Drawing

This is a prospective clinical trial, double-blind, comparative, randomized, single center, performed on quaternary level hospital involving patients with portal hypertension with gastric varices type 2 GOV or IGV 1.

28 cirrhotic patients will be randomized to the treatment of gastric varices type GOV2 IGV1 or more cyanoacrylate Cyanoacrylate or only patients with splenorenal shunt or gastrorenal spring.

After signing the consent form, patients will undergo CT angiography to evaluate the presence of shunt and classification of the same. Patients without shunt will be excluded from the protocol.

Dopller colored portal system will also be conducted in all patients prior to treatment for analysis of portal flow.

After confirming the presence of shunt patients will be examined by echo-endoscopy for completion of treatment The following data will be collected: demographic data (age and gender), etiology of cirrhosis, degree of liver function, primary or secondary prophylaxis diameter of gastric varix, varices of the esophagus with or without signs of red color, size and type of shunt detected by CT, amount of springs inserted, number of ampoules of Cyanoacrylate injected complications (bleeding, damage to the endoscope by cyanoacrylate)


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
Study Start Date : August 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arm Intervention/treatment
Active Comparator: Cyanoacrylate

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

Treatment: cyanoacrylate

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

Sham Comparator: Coil + cyanocrylate

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

Treatment: coil + cyanoacrylate

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




Primary Outcome Measures :
  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. [ Time Frame: Four months after patient recruitment. ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Refusal of the patient or their legal guardian.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115061


Contacts
Contact: Ana C Cândido 55-11-26619577 ana.candido@hc.fm.usp.br
Contact: Maíra R de Almeida 55-11-26617579 mairaralmeida@hotmail.com

Locations
Brazil
Hospital das Clínicas da FMUSP Recruiting
São Paulo, SP, Brazil, 05403000
Contact: Maíra R de Almeida    55-11-26619577    mairaralmeida@hotmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Chair: Maíra R de Almeida Hospital das Clínicas da FMUSP
Principal Investigator: Dalton Chaves Hospital das Clínicas FMUSP

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02115061     History of Changes
Other Study ID Numbers: 02621613100000068
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: April 15, 2014
Last Verified: August 2012

Keywords provided by University of Sao Paulo General Hospital:
Gastric varices,coil,cyanoacrylate,treating gastric varices.

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases