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.
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
- 否
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
Yanglin Pan
Associated professor
Air Force Military Medical University, China
