Relationships Between Intestinal Ultrasound Parameters and Elastography Measurements With Histopathologic Findings in a Prospective Cohort of Patients With Ulcerative Colitis: Development of Novel Imaging and Molecular Biomarkers of Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To correlate ultrasound findings with histopathological elements of lesions
研究概览
简要总结
Prospective multicenter interventional non-randomized cross-sectional study. Ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings.
This study aims to develop novel imaging and molecular biomarkers of fibrosis, through the use of intestinal ultrasound and shear wave elastography, using histologic specimens obtained by endoscopic biopsies as 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
- Other
- 盲法
- None
盲法说明
Ultrasound and endoscopy will be performed within 7 days in blinded fashion, where the ultrasound operators will be blinded to clinical and endoscopic findings and the endoscopist will be blinded of the clinical and ultrasound findings.
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
- •Adult, 18 years of age and older,
- •Established diagnosis (> three months) of ulcerative colitis,
- •Performing colonoscopy, according to current standards of care and ECCO guidelines,
- •Ability to understand and comply with the study procedure and sign an informed consent form
排除标准
- •Pregnancy,
- •presence of ascites, active infections, any contraindication to colonoscopy (e.g. intolerance to preparation, severe flare),
- •inability to undergo intestinal ultrasound within the time set by the study,
- •poor quality of ultrasound imaging (due to luminal gas or body habitus), or a diagnosis of malignancy in the pathological specimen.
- •subjects who needs to change therapy
研究组 & 干预措施
to develop novel imaging and molecular biomarkers of fibrosis
50 Consecutive adult (18 years of age and older) patients, undergoing routine investigations by colonoscopy or sigmoidoscopy, will be enrolled and undergone routine biopsies in the distal colon and intestinal ultrasound with Shear wave elastography measurements.
干预措施: to determine molecular and epigenetic biomarkers (Procedure)
结局指标
主要结局
To correlate ultrasound findings with histopathological elements of lesions
时间窗: 1 day
To correlate ultrasound findings with histopathological elements of lesions obtained by biopsies of the distal colon during routine investigations by colonoscopy or sigmoidoscopy, as the reference standard: specifically, Hematoxylin and Eosin (H\&E) staining for inflammation, Immunostaining of alfa-smooth muscle actin (aSMA) for muscular hypertrophy, and Sirius red special staining for collagen deposition
次要结局
- To correlate shear wave elastography measurements with histopathological elements of lesions(1 day)
研究者
Mariangela Allocca
Gastroenterologist
IRCCS San Raffaele