N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Primary Purpose
Gastric Varices
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
injection sclerotherapy for gastric varices
Sponsored by
About this trial
This is an interventional treatment trial for Gastric Varices
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
N-butyl-2-cyanoacrylate
iso-amyl-2-cyanoacrylate
72% chromated glycerin
Arm Description
injection sclerotherapy for gastric varices
injection sclerotherapy for gastric varices
injection sclerotherapy for gastric varices
Outcomes
Primary Outcome Measures
obturation of gastric varices
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02330731
Brief Title
N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Official Title
N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
October 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
• Study Design & Sampling: This prospective randomized study is conducted on ninety patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital. Patients with non-variceal causes for upper GIT bleeding and those with severe co-morbidity are excluded.
Patients are randomly allocated into three groups; each group includes 30 patients who will be treated with sclerosant injections in biweekly sessions till complete obturation of gastric varices, with follow up for 3 months:
Group I (Histoacryl® Group),
Group II (Amcrylate® Group) and
Group III (Scleremo® with Glucose 25% Group). The three groups are matching as regards age, gender, cause of liver cirrhosis (viral hepatitis B or C), Child score and endoscopic findings (including number, grade of EV and size of GV).
Tools of the study:
All included patients will be subjected to:
Complete clinical evaluation.
Laboratory investigations: CBC, liver profile, viral markers (HBs Ag, HB core Ab, HCV Ab) by ELISA technique.
Child classification according to the modified Child Pugh's criteria [13].
Abdominal ultrasonography: liver and spleen size, portal vein diameter and ascites.
Upper gastrointestinal endoscopy: using Pentax video endoscope EG 3440. Esophageal varices are classified according to their size at the gastroesophageal junction into 4 grades according to Westaby et al. [14].
Gastric varices are classified into: gastro-esophageal varices (GEV) and isolated gastric varices (IGV) according to Sarin et al. [15].
Therapeutic interventions:
The intravariceal technique of injection is done according to Soehendra et al. [16].
Histoacryl® is diluted as 0.5 ml histoacryl: 0.8 ml lipidol as a contrast agent to dilute the adhesive material to fill the whole varix and to prevent rapid hardening and obstruction of the needle. The mixture is injected slowly to minimize the risk of embolization followed by injection of 2 ml of distilled water. The first ml of water is injected to push the material into the varix and the second ml is injected during withdrawal of the needle to prevent its obstruction [8].
Amcrylate® is injected slowly followed by injection of 2 ml distilled water without mixing with any other substances [17].
Scleremo® is mixed with glucose 25% in a ratio of 1:1. The mixture is injected very slowly and with the waiting for moments inside the variceal lumen after injection to give enough time for the sclerosing material to be in contact with the vessel wall that helps haemostasis. There is no need for distilled water injection [11].
Informed consent was obtained from all included patients and the study protocol was approved from the ethical guidelines committee.
All the procedures are done electively without active bleeding. The primary end point of this study is the obturation of gastric varices. The secondary endpoint is the occurrence of bleeding whether from the puncture site during or immediately after injection or delayed (in-hospital or after discharge) and mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Varices
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
N-butyl-2-cyanoacrylate
Arm Type
Other
Arm Description
injection sclerotherapy for gastric varices
Arm Title
iso-amyl-2-cyanoacrylate
Arm Type
Other
Arm Description
injection sclerotherapy for gastric varices
Arm Title
72% chromated glycerin
Arm Type
Other
Arm Description
injection sclerotherapy for gastric varices
Intervention Type
Procedure
Intervention Name(s)
injection sclerotherapy for gastric varices
Intervention Description
The intravariceal technique of injection
Primary Outcome Measure Information:
Title
obturation of gastric varices
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reda Elwakil, MD
Organizational Affiliation
Professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
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