Validation and Interobserver Reliability of an Ultrasonographic Score for the Assessment of Disease Activity in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 124
- 试验地点
- 3
- 主要终点
- Remission
研究概览
简要总结
Crohn's disease (CD) is a chronic inflammatory disease in the gastrointestinal (GI) tract. It is characterized by an alternating course between remission and relapse, which necessitates subsequent adjustments in medical therapy. Thus, it is important to have suitable tools to assess disease activity, and currently the reference standard is using ileocolonoscopy. However, ileocolonoscopy causes major patient discomfort and due to logistic reasons, it cannot be performed on a regular basis. High frequency ultrasound (US) is a potentially useful tool to evaluate changes in disease activity in affected bowel segments. Although there are some studies using US in CD patients to construct ultrasonographic scoring systems, there are no validated scores in daily clinical practice. In a recent study by Nylund et al, we used multiple linear regression to select which simple conventional ultrasound parameters that should be included in an ultrasound scoring system (Simple Ultrasound Score of Crohn's Disease (SUS-CD)) using endoscopy as a reference (unpublished data). In this study, we aim to validate this scoring system using an endoscopic score (Simple endoscopic activity score for Crohn's disease (SES-CD)) as reference standard and to assess interobserver variability.
The scoring system might be a useful supplement to endoscopy to follow up CD patients.
详细描述
Although there are some studies where they used conventional ultrasound and contrast enhanced ultrasound (CEUS) on CD patients to construct ultrasonographic scoring systems, there is currently no validated scores used in daily clinical practice. Even though CEUS provides potentially useful information, the method requires extensive sonographic training, high-end scanners and is time-consuming, making this technique less suitable in daily life. In contrast, conventional ultrasound can be performed using portable ultrasound system and requires less training. Furthermore, evidence suggests that bowel wall thickness predicts endoscopic remission better than CEUS. Thus, conventional ultrasound should be used to construct an ultrasonographic scoring system.
In a recent study, we used multiple linear regression to select which simple conventional ultrasound parameters that should be included in an ultrasound scoring system (Simple Ultrasound Score of Crohn's Disease (SUS-CD)) using endoscopy as a reference. In this study, the primary objective is to validate the SUS-CD scoring system using a validated endoscopic score (Simple endoscopic activity score for Crohn's disease (SES-CD)) as reference standard and further to assess interobserver variability. Secondary objectives are to assess if changes in the SUS-CD score correlate to clinical and biochemical disease activity parameters used in CD, and to examine if SUS-CD could be used to predict treatment effect.
Intervention:
All patients will be examined with trans-abdominal ultrasound and ileocolonoscopy, and relevant blood and faeces samples will be collected.
Ultrasound:
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Crohn's Disease scheduled for ileocolonoscopy.
排除标准
- •<18 years
- •>75 years
- •CD located in other areas than the terminal ileum or colon
- •pregnancy
- •chronic obstructive lung disease
- •acute coronary heart disease
- •clinically unstable heart disease
- •ongoing gastroenteritis
- •presence of an intra-abdominal abscess or a fistula
- •obesity (BMI>30 kg/m2)
结局指标
主要结局
Remission
时间窗: Follow up period (12 months)
The primary outcome measure is clinical and biochemical remission at 12 months (defined as Simple index \<5, Calprotectin\<250, C reactive protein (CRP)\<5 and no steroids). For patients examined with ileocolonoscopy as part of regular follow up after 8-16 months the end-point will be mucosal healing (defined as SES-CD 0-2).
次要结局
未报告次要终点