Intestinal Ultrasound Role in the Management of Pediatric Inflammatory Bowel Disease: A Prospective Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change in bowel wall thickness according to therapeutic regimen
研究概览
简要总结
Objectives: To assess the predictive value of IUS in children with IBD.
Design: A prospective longitudinal cohort study.
Setting: Institute of Gastroenterology, Nutrition and Liver Diseases, Schneider Children's Hospital.
Participants: Children 2 years to 17 years (up to 200 patients) who have been diagnosed with either CD or UC.
Main outcome measures: The changes in bowel wall thickness, assessed by IUS, during 2-year follow-up according to therapeutic regimen.
Secondary outcome measures: Correlation of sonographic measures to clinical disease indices, serum inflammatory and other laboratory markers, fecal calprotectin, endoscopic and other radiologic measures performed as part of routine care.
详细描述
Hypothesis:
The investigators hypothesize that bowel wall thickness as measured routinely by IUS has a role in predicting short- and long-term disease outcomes such as flares, hospitalizations, treatment escalation and surgery.
Objectives:
Primary Objectives:
To assess the changes in bowel wall thickness, assessed by IUS, during 2-year follow-up, according to therapeutic regimen and to evaluate its predictive significance on disease outcomes (flares, hospitalizations, treatment escalation and surgery).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 2 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of IBD
- •Age: 2- 17 years (inclusive)
- •Informed consent
排除标准
- •Morbid obesity
结局指标
主要结局
Change in bowel wall thickness according to therapeutic regimen
时间窗: Two years
次要结局
- Change in bowel wall thickness in comparison to inflammatory markers(Two years)
- Change in bowel wall thickness in comparison to fecal calprotectin(Two years)
- Change in bowel wall thickness in comparison to pediatric ulcerative colitis activity index in ulcerative colitis(Two years)
- Change in bowel wall thickness in comparison to pediatric Crohn's disease severity index in Crohn's disease(Two years)
研究者
Amit Assa
Head of IBD program
Schneider Children's Medical Center, Israel