A Randomized Controlled Non-Inferiority Trial Comparing Neoplasia Detection During Colonoscopy Screening With and Without Non-Targeted Biopsies in Adult Colonic Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,411
- 试验地点
- 16
- 主要终点
- Proportion of persons with ≥ 1 neoplastic lesion detected
研究概览
简要总结
We will conduct a multicenter, parallel-group, non-inferiority RCT in persons with IBD undergoing colorectal neoplasia screening with high-definition white light colonoscopy, comparing a strategy of sampling visible lesions alone to a conventional strategy of sampling both visible lesions as well as normal-appearing mucosa using non-targeted biopsies. The primary outcome is the neoplasia detection rate. The required sample size to demonstrate non-inferiority is 1952 persons.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Each potential participant must satisfy all of the following criteria to be enrolled in the study.
- •≥ 18 years old
- •Historical endoscopic/histologic disease extending beyond the rectum in UC or involving ≥ 1/3 of colorectum in CD> 50% of colon present, with remaining colon meeting above minimum criteria for disease extent (beyond rectum in UC, ≥1/3 colorectum in CD)
- •cIBD ≥ 8 years duration (or at any time after diagnosis if a patient also has primary sclerosing cholangitis)
- •In symptomatic remission at time of colonoscopy
- •For CD: Harvey-Bradshaw Index < 541
- •For UC or IBDU: Partial Mayo Score ≤ 242
- •Major purpose of colonoscopy is neoplasia screening/surveillance
- •Undergoing colonoscopy with high-definition white light endoscopy
排除标准
- •Persons who are unable to provide informed consent
- •Persons with a history of colorectal cancer
- •Persons with prior subtotal or total colectomy (>50% of colon removed)
- •Persons undergoing repeat colonoscopy to follow-up on recently diagnosed neoplasia identified within the past year
- •Persons undergoing pancolonic chromoendoscopy or pancolonic virtual chromoendoscopy
- •Colon mucosa visibility deemed inadequate for surveillance after washing/suctioning (Boston Bowel Preparation Score of 0 or 1 in any segment)
- •Incomplete colonoscopy (unable to reach cecum or terminal ileum [if no cecum])
- •Moderate-to-severe inflammation (Mayo 2-3) involving ≥ 25% of colorectum or mild inflammation (Mayo 1) involving ≥ 50% of colorectum
研究组 & 干预措施
Experimental: Intervention Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy targeted biopsies (biopsies of any areas suspicious for neoplastic/dysplastic lesions observed by the doctor) and/or removal of any polyps will be undertaken. A limited number of disease staging biopsies from each segment of the colorectum will be permitted.
干预措施: Standard colonoscopy with targeted biopsies (Procedure)
Control Group
Participants will undergo standard colonoscopy as part of their routine IBD surveillance. During this colonoscopy both random (approximately 32 to 40 non-targeted biopsies) and targeted sampling (biopsies and/or removal of suspicious pre-cancerous lesions) will be undertaken.
结局指标
主要结局
Proportion of persons with ≥ 1 neoplastic lesion detected
时间窗: 4 years
次要结局
- Mean procedure time(4 years)
- Mean number of neoplastic lesions per person(4 years)
- Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancers detected(4 years)
- Mean # tissue samples per person(4 years)
- Mean # high grade dysplastic lesions or colorectal cancers per person(4 years)
- Proportion of persons referred for colectomy based on neoplastic findings(4 years)
- Rate of major adverse events within 2 weeks of procedure (as per pilot study)(4 years)
- CRC incidence over five years following study colonoscopy (obtained through patient linkage to provincial cancer registries five years following trial completion)(4 years)
- Mean time to next recommended surveillance examination(4 years)
- Proportion of persons with ≥ 1 high grade dysplastic lesion or colorectal cancer(4 years)
- Mean # non-targeted (random) biopsies per person(4 years)