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临床试验/NCT04034563
NCT04034563Unknown不适用

Post-polypectomy Surveillance Interval In High-risk Subjects After Screening Colonoscopy (PPSHR).

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
270
试验地点
2
主要终点
Advanced neoplasia detection rate

研究概览

简要总结

With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.

详细描述

The aim of the study is to determine whether the risk of metachronous advanced neoplasia increases if surveillance interval was beyond the current recommendation of 3 years for high-risk subjects with advanced adenoma polyp at screening colonoscopy.

With many countries initiating population colorectal cancer (CRC) screening, including Hong Kong, more robust guidance for surveillance interval is required to maximize subject's benefit with optimal use of resources. Surveillance interval after removal of advanced adenoma at screening colonoscopy remains unclear. The current recommendation of 3-year is based on data collected before widespread implementation of population screening programs and quality metrics in colonoscopy. These high-risk subjects are those most likely to benefit from surveillance and represent the majority of the demand in surveillance colonoscopies.

The investigators hypothesize that the risk of metachronous advanced neoplasia significantly increases if surveillance interval was prolonged beyond 3 years for high-risk subjects. If such is true, our study's findings will provide definitive evidence to existing guidelines and the future Hong Kong population CRC screening programme of setting surveillance interval at 3-year. Conversely, if our study shows that there is no significant increase in risk beyond 3-year surveillance interval, an extended interval of 5-year is justified.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
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

  • Advanced adenoma at screening colonoscopy
  • ≥3 adenomas at screening colonoscopy
  • Cecal intubation at screening colonoscopy (preferably documented by images/video of the apendiceal orifice and the ileocecal valve; but not required)
  • Complete excision of all polyps at screening colonoscopy findings (after review of endoscopy reports and pathological specimens)
  • Eligible for surveillance in out-patient setting

排除标准

  • Lack of consent
  • Incomplete screening colonoscopy
  • Incomplete endoscopic excision of polyps at screening colonoscopy
  • CRC at screening colonoscopy
  • Polyps requiring Endoscopic Submucosal Dissection at screening colonoscopy
  • Serrated polyps ≥ 10 mm in diameter at any colorectal location or ≥ 5 mm if located proximal to the splenic flexure on screening colonoscopy
  • Genetic cancer syndrome (adenomatous or serrated polyposis syndrome; Lynch or Lynch-like syndrome)
  • Inflammatory bowel disease
  • History of surgical colon resection for any reason
  • Severe co-morbidity with reduced life expectancy (NYHA 3-4)

研究组 & 干预措施

Risk of advanced neoplasia at 3-year

Other

Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy at 3-years

干预措施: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy (Procedure)

Risk of advanced neoplasia beyond 3-year

Other

Risk of metachronous advanced neoplasia in those patients who done surveillance colonoscopy beyond 3-years

干预措施: 1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy (Procedure)

结局指标

主要结局

Advanced neoplasia detection rate

时间窗: Up to 3 months

Advanced neoplasia detection rate in surveillance colonoscopy among the two groups of patients

次要结局

  • CRC detection rate(Up to 3 months)

研究者

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

Joseph JY SUNG

Professor

Chinese University of Hong Kong

研究点 (2)

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