Back-to-back High-definition White Light Endoscopy Versus Single-pass High-definition White Light Endoscopy and Chromoendoscopy in IBD Surveillance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 563
- 试验地点
- 7
- 主要终点
- detection rate of neoplasia for each technique
研究概览
简要总结
The current international guidelines for CRC surveillance in IBD recommend as first choice the use of chromoendoscopy, and as an alternative high-definition white light endoscopy (HDWLE) for optimal dysplasia detection, based on data from clinical trials. However, data on the superiority of CE over HDWLE are not consistent in literature. The investigators hypothesize that the better performance of CE in some clinical trials is the result of the associated longer procedural time and the fact that every colon segment is examined twice. Currently, no studies have been published evaluating the dysplastic yield of back-to back HDWLE compared to HDWLE with a single pass or CE in patients with IBD. In the present study, the investigators aim to compare the yield of dysplasia/CRC between 1) regular HDWLE, 2) HDWLE back-to-back, and 3) CE.
详细描述
The investigators assume based on previous research a yield of 12% using high-definition white light endoscopy and 24% using either chromoendoscopy or high-definition white light endoscopy with a second examination (Imperatore et al 2019). To show non-inferiority of back-to-back HDWLE compared to CE, with a non-inferiority margin of 10% (power 80% and alpha 5%,) a total of 226 patients per group is required.
To demonstrate a superiority of back-to-back HDWLE compared to a regular HDWLE, with a 1:2 allocation ratio of single-pass vs back-to-back , 113 and 226 patients per group are needed to achieve 80% power with an alpha of 5%. Therefore, the investigators will include 226 patients in group back-to-back HDWLE, 226 in group CE, and 113 patients in group regular HDWLE. This amounts to a total of 560 patients. To account for any screen-failures The investigators will include at most 5% (of 560) additional patients until 80% power is reached.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •Signed informed consent
- •Patients with inflammatory bowel disease, an estimated involvement of at least 30% of the colonic surface and a disease duration of at least 8 years (or any disease duration in case of concomitant primary sclerosing cholangitis).
- •Previous assessable surveillance endoscopy > 1 year
- •Age > 18 years
排除标准
- •Active colitis > 20 cm and/or inflammation resulting in an insufficient surveillance procedure according to the endoscopist.
- •Allergy or intolerance to methylene blue
- •Insufficient bowel cleansing (BBPS <6)
- •Refusing or incapable to agree with informed consent
- •Pregnant women
- •> 50 % of the colon surgically removed
结局指标
主要结局
detection rate of neoplasia for each technique
时间窗: During endoscopy
次要结局
- Number of all lesions for each technique(During endoscopy)
- Number of dysplastic lesions for each technique(After each endoscopy, within one month after the procedure.)
- Kudo classification for each lesion(During endoscopy when a lesion is detected)
- Duration(During endoscopy)
- Percentage of non-interpretable/assessable endoscopies(During endoscopy)
- Number of targeted biopsies taken in the different groups.(During endoscopy)
- Location of the lesion(During endoscopy)
- Size of the lesion in mm(During endoscopy)