Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 270
- 试验地点
- 1
- 主要终点
- Dysplasia Detection Rate
研究概览
简要总结
Dye- spray chromoendoscopy remains the recommended gold standard approach for IBD dysplasia surveillance colonoscopy however recently published European and American guidelines recommend either dye-spray or virtual chromoendoscopy can be used for surveillance. The newer Imaged Enhanced Endoscopy technologies TXI and LCI have not formally been evaluated in IBD surveillance in a randomised controlled trial setting. These modes can easily be applied during colonoscopy and if demonstrated to be effective may save time and eliminate the need for dye-spray chromoendoscopy in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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
- 是
入选标准
- •Patients with inflammatory bowel disease aged 18 to 75 years, that meet Australian recommendations to undergo surveillance colonoscopy will be identified and invited participate in the study.
排除标准
- •Any active disease
- •Inadequate bowel preparation
- •Previous surgical resection involving the colon
- •History of bowel cancer
研究组 & 干预措施
Dye Spray Chromoendoscopy
Patients undergoing surveillance with dye spray chromoendoscopy
干预措施: Image Enhanced Endoscopy Filters (Procedure)
TXI
Patients undergoing surveillance with TXI (Texture and Colour Enhancement Imaging)
干预措施: Image Enhanced Endoscopy Filters (Procedure)
LCI
Patients undergoing surveillance with LCI (Linked Colour Imaging )
干预措施: Image Enhanced Endoscopy Filters (Procedure)
结局指标
主要结局
Dysplasia Detection Rate
时间窗: 2 years
Overall Dysplasia Detection rate
次要结局
- Characterisation of lesions(2 years)
- Withdrawal times(2 years)
研究者
Sherman Picardo
Doctor, Principal Investigator
Royal Perth Hospital