Prospective Study to Evaluate the Role of Shear-Wave Elastography in Predicting the Degree of Intestinal Fibrosis in Patients With Crohn's Disease Who Are Candidates for Surgery - ElChir Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- liver stiffness values useful for assessing intestinal fibrosis and inflammation
研究概览
简要总结
The choice of the optimal timing for surgery in Crohn's disease is a challenging issue and diagnostic tools able to estimate the degree of fibrosis are of great interest in this context. Indeed, inflammatory intestinal loops are more likely to respond to medical therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography, which is a non-invasive and largely available technique for the study of tissue elasticity, is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs histologic examination in patients with stenosing Crohn's disease, showing encouraging results.
Aim of this study is to evaluate the diagnostic agreement between elastographic parameters (mean, median, stability index) and the degree of intestinal fibrosis evaluated on the surgical specimen.
详细描述
Background: The choice of the optimal timing for surgery in Crohn's disease is a challenging issue and diagnostic tools able to estimate the degree of fibrosis are of great interest in this context. Indeed, inflammatory intestinal loops are more likely to respond to medical therapies, wheareas fibrotic loops need to be treated surgically. Shear-wave elastography, which is a non-invasive and largely available technique for the study of tissue elasticity, is very promising and a recent meta-analysis has evaluated its diagnostic accuracy vs histologic examination in patients with stenosing Crohn's disease, showing encouraging results.
Primary aim: to evaluate the diagnostic agreement between elastographic parameters (mean, median, stability index) and the degree of intestinal fibrosis evaluated on the surgical specimen.
Secondary aims:
- To evaluate the relationship between clinical disease activity assessed by the Harvey Bradshaw index and elastographic parameters.
- To evaluate the concordance between three different methods of shear wave elastography (point and 2D) and different machines.
- To identify elastographic cut-offs capable of predicting the presence and degree of fibrosis.
- To evaluate the agreement between elastography and magnetic resonance imaging (MRI) parameters of fibrosis in a subgroup of patients who underwent MRI preoperatively.
Exploratory aims:
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of ileal or ileo-colonic Crohn's disease
- •patients scheduled for elective intestinal resection for Crohn's disease within 30 days from enrollment
- •affected intestinal segment detectable in B-mode ultrasound
排除标准
- •diagnosis of IBD other than Crohn's disease
- •Crohn's disease without ileal involment
- •lack of visualization of affected intestinal tract (eg. obesity)
- •hearth failure
- •known allergy to ultrasound contrast agents
- •pregnancy
- •lactation
结局指标
主要结局
liver stiffness values useful for assessing intestinal fibrosis and inflammation
时间窗: 3 months after surgery
to identify liver stiffness values (kPa) measured with shear-wave elastography that may predict the degree of bowel wall fibrosis or inflammation
次要结局
未报告次要终点
研究者
Zocco Maria Assunta
Prof
Fondazione Policlinico Universitario Agostino Gemelli IRCCS