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结肠镜检查拒绝者粪便潜血试验阳性患者结直肠癌筛查中结肠胶囊与计算机断层结肠成像的比较:一项随机试验。

Colon capsule versus computed tomography colonography for colorectal cancer screening in patients with positive fecal occult blood test who refuse colonoscopy: a randomized trial.

机构信息

Hepatogastroenterology department, Hôpital Edouard Herriot, Hospices Civils de Lyon, Lyon, France.

Lyon 1 University Claude Bernard, Lyon, France.

出版信息

Endoscopy. 2018 Aug;50(8):761-769. doi: 10.1055/s-0044-100721. Epub 2018 Feb 27.

DOI:10.1055/s-0044-100721
PMID:29486502
Abstract

OBJECTIVE

Some patients (10 % - 32 %) with a positive guaiac fecal occult blood test (gFOBT) do not undergo the recommended colonoscopy. The aim of this study was to compare video capsule endoscopy (VCE) and computed tomography colonography (CTC) in terms of participation rate and detection outcomes when offered to patients with a positive gFOBT who did not undergo the recommended colonoscopy.

METHODS

An invitation letter offering CTC or VCE was sent to selected patients after randomization. Acceptance of the proposed (or alternative) procedure and procedure results were recorded. Sample size was evaluated according to the hypothesis of a 13 % increase of participation with VCE.

RESULTS

A total of 756 patients were targeted. Following the invitation letter, 5.0 % (19/378) of patients underwent the proposed VCE and 7.4 % (28/378) underwent CTC, ( = 0.18). Following the letter, 9.8 % (37/378) of patients in the VCE group underwent a diagnostic procedure (19 VCE, 1 CTC, 17 colonoscopy) vs. 10.8 % in the CTC group (41/378: 28 CTC, 13 colonoscopy;  = 0.55). There were more potentially neoplastic lesions diagnosed in the VCE group than in the CTC group (12/20 [60.0 %] vs. 8/28 [28.6 %];  = 0.04). Thus, 15/20 noninvasive procedures in the VCE group (19 VCE, 1 CTC; 75.0 %) vs. 10/28 in the CTC group (35.7 %;  = 0.01) resulted in a recommendation of further colonoscopy, but only 10/25 patients actually underwent this proposed colonoscopy.

CONCLUSION

Patients with a positive gFOBT result who do not undergo the recommended colonoscopy are difficult to recruit to the screening program and simply proposing an additional, less-invasive procedure, such as VCE or CTC, is not an effective strategy.ClinicalTrials.govNCT02558881TRIAL REGISTRATION: Randomized, controlled trial NCT02558881 at clinicaltrials.gov.

摘要

目的

一些(10%~32%)粪便潜血试验(gFOBT)阳性的患者未进行推荐的结肠镜检查。本研究旨在比较胶囊内镜(VCE)和计算机断层结肠成像(CTC)在建议结肠镜检查未进行的情况下,对 gFOBT 阳性患者的参与率和检测结果的影响。

方法

对随机分组后的部分患者发出 CTC 或 VCE 检查的邀请信。记录对建议(或替代)检查的接受情况以及检查结果。根据 VCE 参与率提高 13%的假设,对样本量进行评估。

结果

共纳入 756 例患者。在发出邀请信后,5.0%(19/378)的患者接受了建议的 VCE,7.4%(28/378)的患者接受了 CTC(=0.18)。在发出邀请信后,VCE 组有 9.8%(37/378)的患者接受了诊断性检查(19 例 VCE、1 例 CTC、17 例结肠镜检查),而 CTC 组有 10.8%(41/378:28 例 CTC、13 例结肠镜检查;=0.55)。VCE 组诊断出的潜在肿瘤性病变多于 CTC 组(12/20[60.0%] vs. 8/28[28.6%];=0.04)。因此,VCE 组 15/20 例非侵入性检查(19 例 VCE、1 例 CTC;75.0%)和 CTC 组 10/28 例检查(35.7%;=0.01)推荐进一步行结肠镜检查,但只有 10/25 例患者实际接受了该建议的结肠镜检查。

结论

未行推荐结肠镜检查的 gFOBT 阳性患者难以纳入筛查计划,简单地提出如 VCE 或 CTC 等额外的、侵袭性较小的检查策略并非有效策略。

临床试验注册

ClinicalTrials.gov 注册号 NCT02558881。

试验设计

随机对照试验,ClinicalTrials.gov 注册号 NCT02558881。

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