Choice of colon capsule or colonoscopy versus default colonoscopy in FIT positive patients in the Danish screening programme: a parallel group randomised controlled trial.

However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available.

然而，接受程度各不相同，也有如结肠胶囊内镜（CCE）等替代方法可供选择。

The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting.

在这个背景下，与结肠镜相比，CCE对临床显著性肿瘤的摄取和检测率仍然不明确。

The primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy.

本研究的主要目标是比较CCE和结肠镜在检测高级别肿瘤方面的检出率，研究组可以选择两种程序中的任一种，而对照组只提供结肠镜检查。

Methods

A randomised, intention-to-treattrial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT).

在丹麦进行了一项随机、意向治疗试验，对象为粪便免疫化学试验（FIT）检测呈阳性的结直肠癌筛查参与者。

The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms.

该试验比较了两组之间高级别肿瘤（主要结果）的检出率以及两种方法的接受率。

Results

A total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test.

共向396 676名个体发送了473 684份邀请，其中62.6%的人返回了检测结果。

Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups.

在这些检测中，11 075份检测结果呈阳性（4.5%），两组研究对象之间没有显著差异。

Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods.

在FIT阳性病例中，对照组的结肠镜检查接受率为91.1%，研究组为91.7%，研究组参与者可以选择不同的检查方法。

In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy.

在研究组中，45.8%的参与者偏好CCE，11.4%偏好结肠镜检查，而42.8%的参与者没有偏好，接受了结肠镜检查。

Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy.

最终，69.9%最初选择计算机化结肠检查（CCE）的患者之后被转诊进行结肠镜检查。

The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm.

两组之间的高级别肿瘤检出率相似：研究组为0.67%，对照组为0.64%。

Conclusions

Offering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test.

将结肠腔内镜（CCE）作为结肠镜检查的替代方案，并没有显著改变高级别瘤变的检出率，也没有增加在高依从性结肠镜检查的筛查计划中，对阳性粪便免疫化学试验（FIT）测试后的依从性。

Instead, it led to a very high rate of secondary colonoscopies.

相反，它导致了非常高比例的二次结肠镜检查。

Therefore, CCE cannot be recommended in this setting.

因此，在这种情况下不推荐使用CCE。

trial_registration_number

NCT04049357 (ClinicalTrials.gov).

NCT04049357（ClinicalTrials.gov）。