N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ain Shams University
- Enrollment
- 90
- Primary Endpoint
- obturation of gastric varices
Study Overview
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].
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
obturation of gastric varices
Time Frame: 3 months
Secondary Outcomes
No secondary outcomes reported
Investigators
Sara Abdelhakam
Dr
Ain Shams University
