Department of Surgery, Odense University Hospital, Svendborg, Denmark
Department of Clinical Research, University of Southern Denmark, Odense, Denmark.
BMJ Open Gastroenterol. 2020 Jun;7(1). doi: 10.1136/bmjgast-2020-000411.
The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial.
We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures.
All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858).
The study has been registered with ClinicalTrials.gov under: NCT04049357.
胶囊内镜的使用已成为小肠诊断的一种公认方法，但在大肠诊断中尚未达到同样的整合程度。我们将使用结肠胶囊内镜（CCE）作为粪便免疫化学试验（FIT）和结肠镜检查之间结直肠癌（CRC）筛查的过滤试验。我们旨在通过一项大型临床试验研究该程序的临床性能、人群接受度和经济意义。
我们将随机分配 124214 名有资格参加丹麦南丹麦地区国家 CRC 筛查计划的丹麦公民到干预组或对照组。在提交 FIT 之前，随机分配到干预组的公民将被告知，如果 FIT 阳性，他们有机会进行 CCE 而不是结肠镜检查。在 CCE 中发现的疑似癌症；>3 个大小<10mm 的腺瘤、1 个大小>10mm 的腺瘤或>4 个大小无论大小的腺瘤，将根据常规筛查指南发出结肠镜检查邀请，而疑似低风险息肉的公民将重新进入两年一次的筛查计划。无 CCE 发现的公民将在 8 年内被排除在筛查之外。在对照组中，公民将遵循标准的筛查程序。
所有参与者必须在胶囊摄入前同意。所有收集的数据将按照现行数据保护法规进行处理和存储。已获得地区伦理委员会（参考 S-20190100）和丹麦数据保护局的批准（参考 19/29858）。
该研究已在 ClinicalTrials.gov 上注册：NCT04049357。
