Narrow Band Imaging Versus White Light for the Detection and Miss of Sessile Serrated Lesions：a Multicenter，Random，Back-to-back Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 840
- 试验地点
- 1
- 主要终点
- sessile serrated lesions miss rate(SSLMR)
研究概览
简要总结
Narrow band imaging(NBI) could improve the detection of colorectal lesions, previous investigations demonstrated its potential in detecting not only colorectal adenoma but non-adenomatous polyps, including sessile serrated lesions. But no randomized controlled trials with NBI versus white light imaging(WLI) have been conducted to give a definitive conclusion with statistically significant differences. Therefore, we performed a multicenter, prospective, back to back, randomized controlled trial to compare sessile serrated lesions detection and miss rate of withdraw by NBI and WLI in colonoscopy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients whose age are between 45-85
- •Patients who have indications for screening
- •Patients who have signed inform consent form.
排除标准
- •Patients who have undergone colonic resection
- •Patients with alarming signs and symptoms of colorectal cancer: hematochezia, melena, anemia, weight loss, abdominal mass, positive digital rectal examination
- •Patients with highly suspected or confirmed colorectal cancers by radiographic and laboratory tests
- •Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days before colonoscopy
- •Patients with inflammatory bowel diseases
- •Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
- •Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
- •Patients with therapeutic colonoscopy for existing lesions
- •Patients with failed cecal intubation
- •Patients with poor bowel preparation quality that necessitated a second bowel preparation
- •Patients refusing to participate or to provide informed consent
研究组 & 干预措施
WLI Then NBI Withdrawal Group
After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by white light imaging(WLI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with narrow band imaging(NBI). Stop watch will be utilized to remind endoscopists.
干预措施: WLI Then NBI Withdrawal (Procedure)
NBI Then WLI Withdrawal Group
After successful intubation of the cecum, carefully inspect the whole colorectal mucosa by narrow band imaging(NBI) during the first colonoscopy withdraw. Then reinsert to the cecum and withdraw with white light imaging(WLI). Stop watch will be utilized to remind endoscopists.
干预措施: NBI Then WLI Withdrawal (Procedure)
结局指标
主要结局
sessile serrated lesions miss rate(SSLMR)
时间窗: 60 minutes
Sessile serrated lesions(SSLs) detected in the second-pass examination were defined as missed SSLs; the sessile serrated lesions miss rate(SSLMR) was defined as follows: number of SSLs detected in the second-pass examination/total number of SSLs detected in both two pass.
次要结局
- sessile serrated lesions detection rate(SSLDR)(60 minutes)
- adenoma detection rate(ADR)(60 minutes)
- adenoma miss rate(AMR)(60 minutes)
研究者
Zhaoshen Li
MD,Director, Head of Department of Gastroenterology and Digestive Endoscopy Center, Principal Investigator
Changhai Hospital