Stricture Definition and Treatment (STRIDENT) Observational Study.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Development of symptoms
研究概览
简要总结
Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to determine biochemical and imaging features associated with the development of strictures and in related STRIDENT studies develop strategies for treatment.
详细描述
Patients with asymptomatic Crohn's disease strictures will be followed prospectively for 12 months using imaging (including MRI/intestinal ultrasound) and biochemical analyses (including CRP/calprotectin). Patient's with symptomatic or asymptomatic ulcerative colitis related strictures will be followed similarly. Risk factors for progression of strictures and development of symptoms will be identified.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy but without associated symptoms
排除标准
- •Low rectal or anal strictures
- •Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies
- •Patients for whom endoscopy is not suitable due to co-morbidities or clinical state
- •Inability to give informed consent
- •Suspected perforation of the gastrointestinal tract
- •Inability to undergo MRI small bowel due to a contraindication.
结局指标
主要结局
Development of symptoms
时间窗: 12 months
Number of patients who develop symptoms and require step up in therapy (drug, endoscopic or surgical therapy).
次要结局
- Imaging features associated with development of symptoms (Intestinal Ultrasound).(12 months)
- Imaging features associated with development of symptoms (MRI).(12 months)
- Biochemical features associated with development of symptoms(12 months)
- Patient reported outcomes(12 months)
- Requirement for step up in drug therapy(12 months)
研究者
Michael Kamm
Professor of Gastroenterology
St Vincent's Hospital Melbourne