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Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02115061
Enrollment
28
Registered
2014-04-15
Start date
2013-08-31
Completion date
2014-10-31
Last updated
2014-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Varices

Keywords

Gastric varices,coil,cyanoacrylate,treating gastric varices.

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.

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)

Interventions

DEVICETreatment: coil + cyanoacrylate

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

DEVICETreatment: cyanoacrylate

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

Sponsors

University of Sao Paulo General Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
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.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.

Countries

Brazil

Contacts

Primary ContactAna C Cândido
ana.candido@hc.fm.usp.br55-11-26619577
Backup ContactMaíra R de Almeida
mairaralmeida@hotmail.com55-11-26617579

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026