The Comparison of the Efficiency of Colon Capsule Endoscopy and Optical Colonoscopy in Patients With Positive Immunochemical Fecal Occult Blood Test
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
研究概览
简要总结
Main objective is to improve colorectal cancer (CRC) screening programme in the Czech Republic and decrease the disease incidence and mortality. The secondary aim is to verify the effectiveness of incorporation of the new minimally invasive device in the prevention programme.
详细描述
Multicentre, multidisciplinary (3 gastroenterology units; biostatistics department; cooperation with general practitioners), prospective study is focused on examination of individuals with average colorectal cancer (CRC) risk (asymptomatic, age 50-75 years).
In years 2017 - 2019, there will be 230 persons with positive semi-quantitative immunochemical fecal occult blood tests (FIT; QuikRead, Orion Diagnostica Oy, Finland) with cut-off level 75 ng/ml involved. Every person will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
Main objective is to show that the negative predictive value (NPV) of the CCE2 applied in patients with positive FIT results is sufficient to include this method in the National CRC screening as filter test with aim to reduce the necessity of subsequent optical colonoscopy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 50 - 75 years
- •asymptomatic (no enterorhagy, weight loss or anemia)
- •signed informed consent with the study and with colonoscopy
排除标准
- •CRC high-risk group patients
- •having first degree relatives diagnosed with colorectal cancer at age ˂ 60 years
- •FAP, HNPCC and other hereditary CRC syndromes probands
- •positive personal medical history of colorectal neoplasia (advanced adenomatous polyp, colorectal cancer)
- •recent diagnostic, follow-up or preventive colonoscopy in ≤ 3 years (FOBT-positive colonoscopy, screening colonoscopy)
- •colonoscopy contraindication
- •severe acute inflammatory bowel disease
- •severe comorbidities; likely non-compliance of the patient
- •no informed consent signed (with the study and/or with colonoscopy)
研究组 & 干预措施
Pillcam® COLON 2 Capsule and colonoscopy
Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
干预措施: Pillcam® COLON 2 Capsule (Device)
Pillcam® COLON 2 Capsule and colonoscopy
Persons with positive immunochemical fecal occult blood tests will be examined by second generation colon capsule endoscopy (CCE2) and optical colonoscopy afterwards.
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Negative predictive value (NPV) of the CCE2 for large polyps (≥ 10 mm)
时间窗: 1 day
次要结局
- CCE2 accuracy for detection of advanced adenomas(1 day)
- CCE2 and optical colonoscopy acceptance (special questionnaire)(1 day)
- Cost-effectiveness analyses: cost reduction of preventive colonoscopies spared(1 day)
- CCE2 accuracy for detection of colon cancer(1 day)
研究者
Stepan Suchanek, MD., Ph.D.
Head of Department of Gastrointestinal Endoscopy
Military University Hospital, Prague