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临床试验/NCT07467928
NCT07467928招募中不适用

The Long-term Effect of Artificial Intelligence-assisted Colonoscopy on Risk of Metachronous Advanced Colonic Lesion

The University of Hong Kong1 个研究点 分布在 1 个国家目标入组 404 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
404
试验地点
1
主要终点
the cumulative risk of metachronous advanced colonic lesions

研究概览

简要总结

The goal of this prospective study is to to evaluate the prevalence of metachronous advanced colonic lesions in subsequent surveillance colonoscopies in patients who had previously undergone AI-assisted colonoscopy to conventional colonoscopy examinations.

The main question it aims to answer is whether employing AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies.

Researchers will compare patient who undergo conventional colonoscopy in previous colonoscopy to see if AI-assisted colonoscopy can decrease the likelihood of metachronous advanced colonic lesions during subsequent surveillance colonoscopies. Participants will undergo surveillance colonoscopy to assess the presence of metachronous advanced colonic lesion

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Eligible participants are those who were previously enrolled and completed our randomized controlled trial comparing AI-assisted and conventional colonoscopy

排除标准

  • In addition to the baseline exclusion criteria of the index trial, patients who were found to have inflammatory bowel disease, colorectal cancer and underwent bowel resection would be excluded. Similar to index trial, patients who have developed severe comorbid illnesses that make surveillance colonoscopy and polypectomy unsafe, or become unable to provide informed consent for trial participation would also be excluded
  • Index trial: Lui TK, Lam CP, To EW, Ko MK, Tsui VWM, Liu KS, et al. Endocuff With or Without Artificial Intelligence-Assisted Colonoscopy in Detection of Colorectal Adenoma: A Randomized Colonoscopy Trial. Am J Gastroenterol. 2024;119(7):1318-25

研究组 & 干预措施

Surveillance colonoscopy

Other

Surveillance colonoscopy

干预措施: Suveillance colonoscopy (Procedure)

结局指标

主要结局

the cumulative risk of metachronous advanced colonic lesions

时间窗: Three years

the cumulative risk of metachronous advanced colonic lesions

次要结局

  • cumulative risk of non-advanced metachronous adenoma and serrated lesions(three years)
  • mean number of metachronous advanced colonic lesions(three years)
  • mean number of metachronous adenomas, advanced adenomas, serrated lesions, and advanced serrated lesions(three years)

研究者

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

Dr. Lui Ka-Luen

Clinical Associate Professor

The University of Hong Kong

研究点 (1)

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