Endoscopic Mucosal Resection for the Diagnosis of a-Ganglionosis, a Controlled Prospective Trial
试验速览
- 阶段
- 1 期
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy.
研究概览
简要总结
The purpose of this study is to compare the diagnostic yield with endoscopic mucosal resection (EMR) in hirschsprung's disease versus that of standard rectal suction biopsy. In order to compare EMR versus rectal suction biopsy, patients' diagnostic specimens will be analyzed by tissue size, the presence of submucosal tissue, and positive acteylcholinesterase staining. Additionally, the proportion of patients who would have required subsequent full thickness surgical biopsy with each technique will be compared. Biopsy results will be compared with clinical data including history, Bristol stool scale, anorectal manometry results and SITZ markers studies. Finally, the estimated costs that would have been incurred with each method will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients offered a rectal suction biopsy
排除标准
- •any contraindication to general anesthesia or conscious sedation
- •contraindication to endoscopy
- •untreated or unmanageable coaguloapathy
- •thrombocytopenia (<50)
- •inability to provide informed consent.
结局指标
主要结局
The major goal of this study is to test the hypothesis that EMR will result in a higher proportion of diagnostic specimens than RSB in patients sent for rectal suction biopsy.
时间窗: April 2009
次要结局
- Secondary outcome variables include the size of the specimen, the presence of ganglionic tissue, the presence of submucosal tissue, and the positivity of the acetylcholinesterase stain.(April 2009)