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临床试验/NCT06266104
NCT06266104招募中不适用

Image Enhanced Endoscopy Technology to Improve the Detection of Colorectal Dysplasia in Patients With Inflammatory Bowel Disease

Royal Perth Hospital2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2024年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
270
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sherman Picardo

Doctor, Principal Investigator

Royal Perth Hospital

研究点 (2)

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