NCT07745842尚未招募不适用
Impact of Linked Color Imaging on Sessile Serrated Lesion Miss Rate: a Multicenter Tandem Rondomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2,072
- 主要终点
- sessile serrated lesions miss rate(SSLMR)
研究概览
简要总结
This prospective, multicenter randomized controlled trial aimed to investigate whether linked color imaging (LCI) could reduce the miss rate of sessile serrated lesions (SSLs) during tandem colonoscopy compared with conventional white-light imaging (WLI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged ≥45 years, regardless of gender;
- •Subjects undergoing screening colonoscopy;
- •Subjects with no prior colonoscopy;
- •Voluntarily provide written informed consent.
排除标准
- •Subjects unable to cooperate with or tolerate colonoscopy;
- •Subjects with inflammatory bowel disease;
- •Known or highly suspected colorectal obstruction;
- •History of colorectal surgery;
- •Chronic recurrent constipation;
- •Failure to discontinue anticoagulants or antiplatelet agents for at least 1 week before the procedure;
- •Poor bowel preparation with an inadequate Aronchick scale score during colonoscopy;
- •Failed cecal intubation;
- •High-risk conditions including severe cardiovascular and cerebrovascular diseases, uncorrected severe anemia or active infection;
- •Pregnant or breastfeeding women;
- •Subjects deemed ineligible for participation in this trial at the investigator's discretion.
结局指标
主要结局
sessile serrated lesions miss rate(SSLMR)
时间窗: One day
The number of SSL detected in the second-pass examination/total number of SSL detected in both two pass.
次要结局
- adenoma miss rate (AMR)(One day)
- advanced adenomas miss rate (AAMR)(One day)
- polyps miss rate (PMR)(One day)
- sessile serrated lesions detection rate (SSLDR)(One day)
- adenomas detection rate (ADR)(One day)
- advanced adenomas detection rate (AADR)(One day)
- polyps detection rate (PDR)(One day)
研究者
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