Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
Primary Purpose
Gastric Varices
Status
Unknown status
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Treatment: coil + cyanoacrylate
Treatment: cyanoacrylate
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Varices focused on measuring Gastric varices,coil,cyanoacrylate,treating gastric varices.
Eligibility 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.
Sites / Locations
- Hospital das Clínicas da FMUSPRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Cyanoacrylate
Coil + cyanocrylate
Arm Description
This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate. Treatment: cyanoacrylate
This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate. Treatment: coil + cyanoacrylate
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02115061
First Posted
April 3, 2014
Last Updated
April 11, 2014
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02115061
Brief Title
Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
Official Title
Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varices
Keywords
Gastric varices,coil,cyanoacrylate,treating gastric varices.
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cyanoacrylate
Arm Type
Active Comparator
Arm Description
This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.
Treatment: cyanoacrylate
Arm Title
Coil + cyanocrylate
Arm Type
Sham Comparator
Arm Description
This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.
Treatment: coil + cyanoacrylate
Intervention Type
Device
Intervention Name(s)
Treatment: coil + cyanoacrylate
Other Intervention Name(s)
Coil + cyanoacrylate
Intervention Description
This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.
Intervention Type
Device
Intervention Name(s)
Treatment: cyanoacrylate
Other Intervention Name(s)
Cyanoacrylate
Intervention Description
This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
Four months after patient recruitment.
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ana C Cândido
Phone
55-11-26619577
Email
ana.candido@hc.fm.usp.br
First Name & Middle Initial & Last Name or Official Title & Degree
Maíra R de Almeida
Phone
55-11-26617579
Email
mairaralmeida@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maíra R de Almeida
Organizational Affiliation
Hospital das Clínicas da FMUSP
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Dalton Chaves
Organizational Affiliation
Hospital das Clínicas FMUSP
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital das Clínicas da FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maíra R de Almeida
Phone
55-11-26619577
Email
mairaralmeida@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
Gastric Varices Treatment: Coil + Cyanoacrylate Versus Cyanoacrylate
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