Role of Peridiverticular and Colonic Mucosa Inflammation Based on Confocal Laser Endomicroscopy in the Prediction of Complicated Diverticular Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- ocurrence of complicated diverticular disease
研究概览
简要总结
Confocal laser endomicroscopy detects inflammatory markers undetectable during high definition endoscopy. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of the complicated diverticular disease using confocal laser endomicroscopy evaluation in the peridiverticular area in consecutive patients.
详细描述
Diverticular disease of the colon is a prevalent condition in the western hemisphere. Currently there is an endoscopic classification system for classifying diverticular disease; however, white light endoscopic fails to accurately detect inflammation.
Confocal laser endomicroscopy offers a real-time, in-vivo evaluation of the colonic mucosa, with an adequate correlation to histological findings. The investigators aimed to evaluate the role of peridiverticular and colonic mucosa inflammation in the prediction of complicated diverticular disease.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Above 18 years old
- •Writeen informed consent provided.
- •Endoscopic visualization of diverticular disease during colonoscopy.
- •Adequate bowel preparation BBPS >2 in each colon segment
排除标准
- •Under 18 years old.
- •Refuse to sign written informed consent.
- •Pregnancy or nursing.
- •Previous colorectal surgery
- •History of colorectal cancer
- •Known allergy to fluorscein
- •Uncontrolled coagulopathy
- •History of complicated diverticular disease
- •Patients with inflammatory bowel disease
- •Patients with severe comorbidities: kidney and liver failure
- •NSAIDs and antibiotics two weeks prior enrollment
- •Historyh of alcohol or drug abuse
- •Patients with severe mental illness
- •Patients with incomplete evaluation of the colon
结局指标
主要结局
ocurrence of complicated diverticular disease
时间窗: up to 24 months
To predict the ocurrence of complications in colonic diverticular disease based on pCLE findings
次要结局
- DICA classification(index procedure)
- ocurrence of surgical intervention(12 months and 24 months)
- peridiverticular and colonic mucosa inflammation based on pcle(index procedure)
- ocurrence of complicated diverticular disease(12 months and 24 months)
研究者
Carlos Robles-Medranda
Head of the Endoscopy Division
Instituto Ecuatoriano de Enfermedades Digestivas