Advanced Endoscopic Imaging Using HD+ Endoscopy and i-Scan for Assessment of Mucosal Healing in IBD
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Mucosal healing
研究概览
简要总结
Inflammatory bowel disease (IBD) encompasses two major forms of chronic intestinal disorders, Crohn's disease and ulcerative colitis (UC). Diagnosis is based on several macroscopic and histologic features including patterns of inflammation, crypt abscesses and granulomas. i-Scan use an endoscopic image from the video processor and reconstruct virtual images in real time, resulting in an improved contrast of the capillary patterns and enhancement of the mucosal surface (so called virtual chromoendoscopy).
The main objective of this study is to determine endoscopic features of mucosal healing in patients with IBD and to compare these features to clinical and histological data in order to establish a new endoscopic classification of mucosal healing and to evaluate mucosal healing as a parameter of remission and relapse.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent
- •Age 18-85 years
- •Ability of subjects to understand character and individual consequences of clinical trial
- •Subjects undergoing colonoscopy
排除标准
- •Inability to provide written informed consent
- •Severe Coagulopathy (Prothrombin time < 50% of control, Partial thromboplastin time > 50 s)
- •Pregnancy or breast feeding
- •Active gastrointestinal bleeding
- •Residing in institutions (e.g. prison)
- •Proctocolectomy
结局指标
主要结局
Mucosal healing
时间窗: up to three years
We will determine high-definition white light endoscopic and i-Scan features of mucosal inflammation (e.g. erosions, erythema, ulcerous lesions) in IBD in order to establish a new endoscopic classification of mucosal healing.
次要结局
- Therapeutic effect(up to three years)
- Histologic correlation(up to three years)