Impact of Artificial Intelligence in Dysplasia Detection During Colonoscopy in Patients With Long-data Ulcerative Colitis: a Crossover Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- "Per patient" dysplasia detection rate (DDR)
研究概览
简要总结
Prospective clinical study that analyzes the efficacy of colonoscopy assisted by an artificial intelligence system (DiscoveryTM) compared to virtual chromoendoscopy with iSCAN in the detection of colon dysplasia in patients with long-standing Ulcerative Colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Screening
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- •Ulcerative Colitis confirmed by endoscopy and histology.
- •Involvement 30% of the colonic surface (or any extent if concomitant with PSC).
- •Duration of the disease >7 years (or any duration if concomitant with PSC).
排除标准
- •Personal history of colorectal cancer or high-grade dysplasia.
- •Previous colectomy (partial or complete).
- •Coagulopathy that prevents biopsies or polypectomy.
- •Colonoscopy performed in the previous 6 months.
- •Pregnant or nursing women.
- •Inadequate bowel preparation.
- •Presence of endoscopic Ulcerative Colitis activity.
- •Colonic stenosis and incomplete colonoscopy.
结局指标
主要结局
"Per patient" dysplasia detection rate (DDR)
时间窗: Immediately after the procedure.
Proportion of patients with dysplastic lesions in relation to all the patients with long-standing Ulcerative Colitis included in the study detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN.
"Per lesion" dysplasia detection rate (DDR)
时间窗: Immediately after the procedure.
Proportion of dysplastic lesions in relation to all the lesions analyzed that were detected by Artificial Intelligence System (DiscoveryTM) or Virtual chromoendoscopy with iSCAN in patients with long-standing Ulcerative Colitis who undergo surveillance colonoscopy.
次要结局
未报告次要终点
研究者
Antonio López-Serrano
Chief of Endoscopy
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana