N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
1 other identifier
interventional
90
0 countries
N/A
Brief Summary
AIM: To compare between n-butyl-2-cyanoacrylate, iso-amyl-2-cyanoacrylate and mixture of 72% chromated glycerin with hypertonic glucose solution in management of gastric varices. METHODS: Ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital were included. They were randomly allocated into three groups; each group included 30 patients treated with intravariceal sclerosant injections in biweekly sessions till complete obturation of gastric varices; Group I (n-butyl-2-cyanoacrylate; Histoacryl®), Group II (iso-amyl-2-cyanoacrylate; Amcrylate®) and Group III (mixture of 72% chromated glycerin; Scleremo® with glucose solution 25%). All the procedures were done electively without active bleeding. Recruited patients were followed up for 3 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2012
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
January 1, 2015
CompletedFirst Posted
Study publicly available on registry
January 5, 2015
CompletedJanuary 5, 2015
January 1, 2015
5 months
January 1, 2015
January 2, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
obturation of gastric varices
3 months
Study Arms (3)
N-butyl-2-cyanoacrylate
OTHERinjection sclerotherapy for gastric varices
iso-amyl-2-cyanoacrylate
OTHERinjection sclerotherapy for gastric varices
72% chromated glycerin
OTHERinjection sclerotherapy for gastric varices
Interventions
The intravariceal technique of injection
Eligibility Criteria
You may qualify if:
- Patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital
You may not qualify if:
- Patients with non-variceal causes for upper GIT bleeding and those with severe co-morbidity
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Reda Elwakil, MD
Professor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
January 1, 2015
First Posted
January 5, 2015
Study Start
January 1, 2012
Primary Completion
June 1, 2012
Study Completion
October 1, 2012
Last Updated
January 5, 2015
Record last verified: 2015-01