乙状结肠镜检查和结肠镜检查替代筛查方案对结直肠肿瘤内镜筛查利用情况和检出率的影响：DARIO随机试验方案

Effects of Alternative Offers of Screening Sigmoidoscopy and Colonoscopy on Utilization and Yield of Endoscopic Screening for Colorectal Neoplasms: Protocol of the DARIO Randomized Trial.

作者信息

Schrotz-King Petra, Hoffmeister Michael, Sauer Peter, Schaible Anja, Brenner Hermann

机构信息

Division of Preventive Oncology, National Center for Tumor Diseases (NCT), German Cancer Research Center (DKFZ), Heidelberg, Germany.

Division of Clinical Epidemiology and Aging Research, German Cancer Research Center (DKFZ), Heidelberg, Germany.

出版信息

JMIR Res Protoc. 2020 Aug 5;9(8):e17516. doi: 10.2196/17516.

DOI:10.2196/17516

PMID:32755890

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7439136/

Abstract

BACKGROUND

Flexible sigmoidoscopy and colonoscopy are recommended screening options for colorectal cancer (CRC). Despite colonoscopy being offered for CRC screening in Germany, the uptake of this offer has been very limited.

OBJECTIVE

The objective of this study was to assess the potential for increasing use of endoscopic CRC screening and the detection of advanced colorectal neoplasms by offering the choice between use of flexible sigmoidoscopy and colonoscopy.

METHODS

The DARIO study includes a cross-sectional study (part I), followed by a prospective 2-arm randomized controlled intervention trial (part II) with an associated biobank study (part III). Participation is possible in part I of the DARIO study only, parts I and II, or all 3 study parts. After obtaining informed consent from the municipalities, 12,000 people, aged 50-54 years, from the Rhine-Neckar region in Germany were randomly selected from residential lists of the responsible population registries and invited to complete a standardized questionnaire to investigate the nature, frequency, timing, and results of previous CRC screening and eventual diagnostic colonoscopies. In study part II participants from study part I with no colonoscopy in the preceding 5 years are randomized into 2 arms: arm A offering screening colonoscopy only, and arm B offering both options, either screening colonoscopy or screening sigmoidoscopy. The primary endpoint is the proportion of participants in whom colorectal neoplasms >0.5 cm are detected and removed at screening endoscopy. The secondary endpoints are the detection rate of any neoplasm and use of any endoscopic screening. Part III of the study will use samples from participants in study part II to construct a liquid and tissue biobank for the evaluation of less invasive methods of early detection of colon cancer and for the more detailed characterization of the detected neoplasms. Blood, urine, stool, and saliva samples are taken before the endoscopy. Tissue samples are obtained from the neoplasms removed during endoscopy.

RESULTS

A total of 10,568 from 12,000 randomly selected women and men aged 50-54 years living in the Rhine-Neckar-Region of Germany have been invited for participation. The remaining 1432 (11.93%) could not be invited because they reached the age of 55 at the time of contact. Of those invited, 2785/10,568 (26.35%) participated in study part I; 53.60% (1493/2785) of these participants were female. Study parts II and III are ongoing.

CONCLUSIONS

This study will answer the question if alternative offers of either screening sigmoidoscopy or screening colonoscopy will increase utilization and effectiveness of endoscopic CRC screening compared with an exclusive offer of screening colonoscopy. In addition, alternative noninvasive screening tests will be developed and validated.

TRIAL REGISTRATION

German Clinical Trials Register DRKS00018932; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00018932.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/17516.

摘要

背景

乙状结肠镜检查和结肠镜检查是推荐的结直肠癌（CRC）筛查方法。尽管德国提供结肠镜检查用于CRC筛查，但这种检查的接受率非常有限。

目的

本研究的目的是评估通过提供乙状结肠镜检查和结肠镜检查之间的选择，增加内镜CRC筛查的使用以及检测进展期结直肠肿瘤的可能性。

方法

DARIO研究包括一项横断面研究（第一部分），随后是一项前瞻性双臂随机对照干预试验（第二部分）以及一项相关的生物样本库研究（第三部分）。参与者可以仅参与DARIO研究的第一部分、第一和第二部分或所有三个研究部分。在获得各市镇的知情同意后，从德国莱茵-内卡地区50至54岁的人群居住名单中随机抽取12000人，邀请他们填写一份标准化问卷，以调查先前CRC筛查的性质、频率、时间和结果以及最终的诊断性结肠镜检查情况。在研究的第二部分中，将第一部分中过去5年内未进行结肠镜检查的参与者随机分为两组：A组仅提供筛查结肠镜检查，B组提供两种选择，即筛查结肠镜检查或筛查乙状结肠镜检查。主要终点是在筛查内镜检查中检测到并切除的直径>0.5 cm的结直肠肿瘤患者的比例。次要终点是任何肿瘤的检测率和任何内镜筛查的使用情况。研究的第三部分将使用第二部分参与者的样本构建一个液体和组织生物样本库，用于评估结肠癌早期检测的微创方法以及对检测到的肿瘤进行更详细的特征描述。在内镜检查前采集血液、尿液、粪便和唾液样本。从内镜检查期间切除的肿瘤中获取组织样本。

结果

在德国莱茵-内卡地区随机抽取的12000名年龄在50至54岁的男女中，共有10568人被邀请参与。其余1432人（11.93%）因在联系时已满55岁而未被邀请。在被邀请者中，2785/10568（26.35%）参与了研究的第一部分；这些参与者中53.60%（1493/2785）为女性。研究的第二和第三部分正在进行中。