N-butyl-2-cyanoacrylate, Iso-amyl-2-cyanoacrylate and Hypertonic Glucose With 72% Chromated Glycerin in Gastric Varices
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- obturation of gastric varices
研究概览
简要总结
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.
详细描述
• 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].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with gastric varices presented to Endoscopy Unit of Ain Shams University Hospital
排除标准
- •Patients with non-variceal causes for upper GIT bleeding and those with severe co-morbidity
结局指标
主要结局
obturation of gastric varices
时间窗: 3 months
次要结局
未报告次要终点
研究者
Sara Abdelhakam
Dr
Ain Shams University
