Comparison of Bowel Ultrasound & MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Follow-up of known small bowel Crohn disease
研究概览
简要总结
To establish the accuracy of bowel ultrasound in the follow-up of known (previously diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance imaging technology used to obtain detailed images of the small bowel) as the reference standard.
详细描述
25-30% of individuals with Crohn disease present during childhood or adolescence, and the incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging technology for bowel assessment and offers several advantages over MRE, including lower cost, shorter exam time, and lack of need for sedation and contrast materials and bowel medication. The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known pediatric small bowel Crohn disease using MRE and the reference standard.
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 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or younger
- •Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging follow-up with MR enterography.
排除标准
- •Subjects with suspected or newly diagnosed Crohn disease
- •Subject who have the following in their body may not undergo MRE imaging:
- •Metal chips/shrapnel
- •Surgical clips
- •Artificial joints
- •Metallic bone plates
- •Prosthetic devices
- •Heart pacemakers
- •Clips in or around the eye balls
- •artificial heart valves
- •Bullet fragments
- •Chemotherapy or insulin pumps
研究组 & 干预措施
Pediatric small bowel Crohn disease
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
干预措施: Bowel ultrasound (Procedure)
Pediatric small bowel Crohn disease
Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
干预措施: magnetic resonance enterography (MRE) (Procedure)
结局指标
主要结局
Follow-up of known small bowel Crohn disease
时间窗: 1 year
A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.
次要结局
未报告次要终点
研究者
Jonathan Dillman, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati