Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

Gastric Varices Clinical Trial

Official title:

Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02115061
• Other study ID #: 02621613100000068
• Status: Recruiting
• Phase: Phase 1
• First received: April 3, 2014
• Last updated: April 11, 2014
• Start date: August 2013
• Est. completion date: October 2014

Study information

• Verified date: August 2012
• Source: University of Sao Paulo General Hospital
• Contact: Ana C Cândido
• Phone: 55-11-26619577
• Email: ana.candido[@]hc.fm.usp.br
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: October 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal and Gastric Varices
• Gastric Varices
• Varicose Veins

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Yes