A Multicenter, Randomized Controlled Trial for Surveillance in Ulcerative Colitis: Narrow Band Image Versus Chromoendoscopy for High-risk Groups
试验速览
- 阶段
- 不适用
- 入组人数
- 188
- 主要终点
- Dysplasia detection rate at first surveillance
研究概览
简要总结
The risk of colorectal cancer (CRC) is increased in patients having ulcerative colitis (UC). Patients with long-standing extensive colitis, concomitant primary sclerosing cholangitis, or previous history of dysplasia carry an exceptionally high risk of CRC and require regular and short-interval surveillance colonoscopy. Recent guidelines recommend surveillance colonoscopy based on target biopsy rather than random biopsy applying chromoendoscopy (CE) or narrow band image (NBI) technique in UC at risk for CRC. However, the diagnostic yield of NBI-based surveillance and CE-based surveillance is not extensively investigated in the high-risk UC population. The investigators aimed to compare the dysplasia detection rate of NBI with that of CE in UC patients with a high risk of CRC by performing a multicenter, randomized controlled trial.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least one of the followings should be satisfied;
- •A patient having extensive ulcerative colitis with 8-year or longer disease duration
- •A patient having both ulcerative colitis and primary sclerosing colitis
- •A patient having a previous history of dysplasia at the colitic segment within recent 5 years
排除标准
- •All of the following conditions should be excluded for 1st surveillance colonoscopy study
- •A patient who underwent total or segment colectomy.
- •A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
- •A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
- •A patient who has a coagulopathy
- •A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation
- •A patient who has already undergone surveillance colonoscopy within 1 year
- •All of the following conditions should be excluded for 2nd surveillance colonoscopy study even if they were included in 1st surveillance study.
- •A patient who underwent total or segment colectomy after 1st surveillance colonoscopy for this trial.
- •A patient who taking (warfarin or direct oral anticoagulants and cannot stop them for procedures owing to the high thromboembolic risk
- •A patient who has known thrombocytopenia (less than 80,000/µL in recent 6 months
- •A patient who has a coagulopathy
- •A patient who has chronic renal disease evidenced by serum creatinine > 1.2 mg/dL within 6 months of study participation
研究组 & 干预措施
NBI-CE
High definition NBI with target biopsy, at 1st surveillance colonoscopy during the trial High definition chromoendoscopy with target biopsy, at 2nd surveillance colonoscopy during the trial
干预措施: chromoendoscopy with target biopsy; NBI with target biopsy (Diagnostic Test)
CE-NBI
High definition chromoendoscopy with target biopsy, at 1st surveillance colonoscopy during the trial High definition NBI with target biopsy, at 2nd surveillance colonoscopy during the trial
干预措施: chromoendoscopy with target biopsy; NBI with target biopsy (Diagnostic Test)
结局指标
主要结局
Dysplasia detection rate at first surveillance
时间窗: 3 months after first surveillance colonoscopy in each arm
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Neoplasia detection rate at first surveillance
时间窗: 3 months after first surveillance colonoscopy in each arm
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
Dysplasia detection rate at second surveillance
时间窗: 3 months after second surveillance colonoscopy in each arm
Any dysplasia within the colitic segments will be counted as "dysplasia" to calculate dysplasia detection rate. A sessile serrated lesion (SSL) with dysplasia located in the colitic segment will be counted as "dysplasia", but SSLs without dysplasia will not be counted as "dysplasia" even if located within colitic segments.
Neoplasia detection rate at second surveillance
时间窗: 3 months after second surveillance colonoscopy in each arm
Neoplasia at any segments (regardless of colitis) will be counted as "neoplasia" to calculate neoplasia detection rate. SSL will be counted as neoplasia
次要结局
- Withdrawal time(3 months after overall surveillance colonoscopy in each arm)
- Endoscopic features of target-biopsied lesions(3 months after overall surveillance colonoscopy in each arm)
- SSL detection rate(3 months after overall surveillance colonoscopy in each arm)
- Total procedure time(3 months after overall surveillance colonoscopy in each arm)
- Procedure-related adverse events(3 months after overall surveillance colonoscopy in each arm)
研究者
Dong-Hoon Yang
Clinical Associate Professor
Asan Medical Center