National Cancer Control Institute, National Cancer Center, 323 Ilsan-ro, Ilsandong-gu, Goyang, Korea.
Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.
BMC Gastroenterol. 2021 Jan 26;21(1):36. doi: 10.1186/s12876-021-01610-1.
The Korean National Cancer Screening Program has been providing annual fecal immunochemical test for colorectal cancer (CRC) to adults aged 50 years and older since 2004. The Korean Colonoscopy Screening Pilot Study was developed to evaluate the effectiveness of colonoscopy screening for CRC incidence and mortality, screening-related complications, and acceptability of colonoscopy as a primary modality for the national CRC screening program.
This study and its protocols have been approved by the Korean Public Institutional Review Board and the National Cancer Center Institutional Review Board. We obtain written informed consent from all participants. The target population is males and females aged 50-74 years living within the pilot sites. A total of 26,640 participants will be recruited for colonoscopy screening. Subjects who have been diagnosed with CRC, who are currently undergoing treatment for CRC, or who have undergone colonoscopy screening within the past 5 years are not allowed to participate. All participants need to complete baseline questionnaires. This pilot study is currently conducted by 104 endoscopists from 57 national cancer screening institutions (42 primary, 10 secondary, and 5 tertiary institutions) located in Goyang-si, Gimpo-si, and Paju-si. The number of endoscopists, medical institutions, and districts participating in the pilot study will be expanded, if necessary. Participating endoscopists at each medical institution perform colonoscopy and report the colonoscopy results to a centralized electronic case report system. We conduct a telephone survey after 7 days and 4 weeks post-colonoscopy to assess for procedure-related complications and satisfaction of the participants. In case of abnormal findings from colonoscopy screening, we track the results from follow-up diagnostic tests. Data from this pilot study will be linked to the diagnostic workup results, the Korean Cancer Registry, and death certificate data for analysis of the performance, long-term effects, and cost-effectiveness of colonoscopy.
The results will provide critical information to determine whether the introduction of colonoscopy as the primary modality of the Korean National Cancer Screening Program would be acceptable and feasible. Trial registration Korean Clinical Research Information Service registry, KCT0004142. Registered on 15 July 2019, http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16227.
自 2004 年以来，韩国国家癌症筛查计划一直为 50 岁及以上成年人提供年度粪便免疫化学检测用于结直肠癌（CRC）筛查。韩国结肠镜筛查试点研究旨在评估结肠镜筛查对 CRC 发病率和死亡率、筛查相关并发症的有效性，以及作为国家 CRC 筛查计划主要模式的可接受性。
本研究及其方案已获得韩国公共机构审查委员会和国家癌症中心机构审查委员会的批准。我们从所有参与者处获得书面知情同意。目标人群是居住在试点地区的 50-74 岁男性和女性。共将招募 26640 名参与者进行结肠镜筛查。患有 CRC、正在接受 CRC 治疗或在过去 5 年内接受过结肠镜筛查的患者不允许参加。所有参与者均需完成基线问卷。目前，该试点研究由来自位于高阳市、金浦市和坡州市的 57 家国家癌症筛查机构的 104 名内镜医生（42 家初级机构、10 家二级机构和 5 家三级机构）进行。如果需要，将扩大参与试点研究的内镜医生数量、医疗机构数量和地区数量。各医疗机构的参与内镜医生进行结肠镜检查，并将结肠镜检查结果报告给集中式电子病例报告系统。结肠镜检查后 7 天和 4 周进行电话调查，评估与程序相关的并发症和参与者的满意度。如果结肠镜筛查发现异常，我们将跟踪后续诊断测试的结果。本试点研究的数据将与诊断工作结果、韩国癌症登记处和死亡证明数据相关联，以分析结肠镜检查的性能、长期效果和成本效益。
研究结果将提供关键信息，以确定将结肠镜检查作为韩国国家癌症筛查计划的主要模式是否可以接受和可行。试验注册 韩国临床研究信息服务注册处，KCT0004142。于 2019 年 7 月 15 日注册，http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16227。
