Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
NCT ID: NCT02115061
Last Updated: 2014-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
28 participants
INTERVENTIONAL
2013-08-31
2014-10-31
Brief Summary
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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.
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Detailed Description
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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)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Cyanoacrylate
This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.
Treatment: cyanoacrylate
Treatment: cyanoacrylate
This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.
Coil + cyanocrylate
This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.
Treatment: coil + cyanoacrylate
Treatment: coil + cyanoacrylate
This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Principal Investigators
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Maíra R de Almeida
Role: STUDY_CHAIR
Hospital das Clínicas da FMUSP
Dalton Chaves
Role: PRINCIPAL_INVESTIGATOR
Hospital das Clínicas FMUSP
Locations
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Hospital das Clínicas da FMUSP
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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02621613100000068
Identifier Type: -
Identifier Source: org_study_id
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