Effect of an Artificial Intelligence System on the Detection of Dysplasia During Colonoscopy in Patients With Long-standing Inflammatory Bowel Disease: a Randomized Study (EIIDISIA Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 122
- 试验地点
- 2
- 主要终点
- "Per lesion" dysplasia detection rate (DDR)
研究概览
简要总结
Randomized clinical study analyzing the efficacy of colonoscopy assisted by the Computer Aided Detection (CADe) system compared to virtual chromoendoscopy with Narrow Band Imaging (NBI) in the detection of colon dysplasia in patients with long-standing inflammatory bowel disease (IBD).
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
- Triple (Participant, 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
- •Adults (age ≥18 years).
- •Patients with IBD meeting the following criteria:
- •Diagnosis of IBD confirmed by clinical and histological evidence.
- •Disease extent (Montreal classification): 1) For Ulcerative Colitis (UC), Extensive colitis (E3): involvement proximal to the splenic flexure; or, Left-sided colitis (E2): involvement distal to the splenic flexure. 2) For Crohn's Disease (CD): Colon-only involvement (L2); or, Ileocolonic involvement (L3).
- •Disease duration > 7 years.
- •Patients with concommitant Primary Sclerosing Cholangitis, regardless of the extent of colonic involvement and disease duration.
- •Written consent from the patient to undergo colonoscopy (signed informed consent).
排除标准
- •Personal history of colorectal cancer (CRC).
- •Previous colectomy (partial or complete).
- •Coagulopathy preventing biopsy or polypectomy/mucosal resection.
- •Colonoscopy performed in the last 6 months.
- •Pregnant or lactating women.
- •Ulcerative colitis with involvement limited to the rectum or Proctitis (Montreal E1).
- •Inadequate colonic preparation due to uncleavable fecal residue during colonoscopy: Boston Bowel Preparation Scale (BBPS) = 0 or 1 in any colon segment.
- •Presence of inflammatory activity due to IBD on endoscopy:1) For UC: Endoscopic Mayo Score ≥
- •For CD: Simplified Endoscopic Activity Score (SES-CD) >
- •Incomplete lower digestive endoscopy (failure to reach the cecum).
研究组 & 干预措施
Colonoscopy assisted by CADe
干预措施: CADe system (Device)
Virtual Colonoscopy with NBI
干预措施: NBI (Device)
结局指标
主要结局
"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 (CADe) or Virtual chromoendoscopy with NBI in patients with long-standing Inflammatory bowel disease who undergo surveillance colonoscopy
"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 Inflammatory bowel disease included in the study detected by Artificial Intelligence System (CADe) or Virtual chromoendoscopy with NBI
次要结局
- Duration of endoscopic examination(Immediately after the procedure)
研究者
Antonio López-Serrano
Chief of Endoscopy Section
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana