跳至主要内容
临床试验/NCT04464135
NCT04464135Unknown不适用

Effect of Water Exchange Plus Acetic Acid Staining on the Detection of Flat Polyps During Screening and Surveillance Colonoscopy: a Multi-centered, Randomized Controlled Study.

Air Force Military Medical University, China4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
4
主要终点
Number of flat polyps per patient

研究概览

简要总结

Our previous study (Am. J. Gastroenterol. 2017 04;112(4)) showed that water exchange (WE) colonoscopy was able to increase the detection of flat adenomas as well as overall ADR. We hypothesized that WE based whole-colon acetic acid(AA) staining might be useful to improve the detection of flat lesions compared with WE alone.

详细描述

Water exchange colonoscopy was performed as described previously (Am. J. Gastroenterol. 2017 04;112(4)). Patients were randomly allocated to WE group or WE+AA group. In WE+AA group, water containing 1% of AA was used during insertion of colonoscopy instead of water alone. A bottle of 20ml pure AA was placed abutting the water pump, which make it possible to keep patients blinded to group allocation. Endoscopist using a high-definition wide-angle Olympus or Fujinum colonoscope performed all of the colonoscopies, with a withdrawal time of at least 6 min. The observation was initially performed without the assistance of cap or the use of magnification or electronic staining (NBI, BLI, LCI or AFI et al.). Scopolamine butylbromide or glucogon was not routinely administrated.

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 (Participant)

入排标准

年龄范围
40 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 40-70
  • Undergoing colonoscopy after standard bowel preparation

排除标准

  • Known familial polyposis
  • Small amount of feces or semi-solid stool in last rectal effluent
  • Inflammatory Bowel Disease
  • Lactated or pregnant women
  • Unable to provide informed content

结局指标

主要结局

Number of flat polyps per patient

时间窗: 9 months

average numbers of flat polyps, defined by Paris classification IIa/IIb/IIc, for each patient

次要结局

  • Adverse events(9 months)
  • Overall ADR(9 months)
  • Advanced ADR(9 months)
  • SSA/P detection rate(9 months)
  • Flat neoplasms located in proximal colon(9 months)

研究者

发起方
Air Force Military Medical University, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanglin Pan

Associated professor

Air Force Military Medical University, China

研究点 (4)

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