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Trial record 18 of 555 for:    varicose veins

N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices

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ClinicalTrials.gov Identifier: NCT02330731
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Sara Abdelhakam, Ain Shams University

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.


Condition or disease Intervention/treatment Phase
Gastric Varices Procedure: injection sclerotherapy for gastric varices Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Study Start Date : January 2012
Actual Primary Completion Date : June 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins
Drug Information available for: Glycerin

Arm Intervention/treatment
N-butyl-2-cyanoacrylate
injection sclerotherapy for gastric varices
Procedure: injection sclerotherapy for gastric varices
The intravariceal technique of injection

iso-amyl-2-cyanoacrylate
injection sclerotherapy for gastric varices
Procedure: injection sclerotherapy for gastric varices
The intravariceal technique of injection

72% chromated glycerin
injection sclerotherapy for gastric varices
Procedure: injection sclerotherapy for gastric varices
The intravariceal technique of injection




Primary Outcome Measures :
  1. obturation of gastric varices [ Time Frame: 3 months ]


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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital

Exclusion Criteria:

  • Patients with non-variceal causes for upper GIT bleeding and those with severe co-morbidity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330731


Sponsors and Collaborators
Ain Shams University
Investigators
Principal Investigator: Reda Elwakil, MD Professor

Responsible Party: Sara Abdelhakam, Dr, Ain Shams University
ClinicalTrials.gov Identifier: NCT02330731     History of Changes
Other Study ID Numbers: 482
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Varicose Veins
Esophageal and Gastric Varices
Vascular Diseases
Cardiovascular Diseases
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases
Glycerol
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs