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BowelScope:使用 Endocuff 优化黏膜病变检测准确性(B-ADENOMA 研究):一项多中心、随机对照、灵活乙状结肠镜检查试验。

BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial.

机构信息

Northern Institute for Cancer Research, Newcastle University, Newcastle upon Tyne, UK

North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, Gwynedd, UK.

出版信息

Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3.

Abstract

OBJECTIVES

Adenoma detection rate (ADR) is an important quality marker at lower GI endoscopy. Higher ADRs are associated with lower postcolonoscopy colorectal cancer rates. The English flexible sigmoidoscopy (FS) screening programme (BowelScope), offers a one-off FS to individuals aged 55 years. However, variation in ADR exists. Large studies have demonstrated improved ADR using Endocuff Vision (EV) within colonoscopy screening, but there are no studies within FS. We sought to test the effect of EV on ADR in a national FS screening population.

DESIGN

BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities was a multicentre, randomised controlled trial involving 16 English BowelScope screening centres. Individuals were randomised to Endocuff Vision-assisted BowelScope (EAB) or Standard BowelScope (SB). ADR, polyp detection rate (PDR), mean adenomas per procedure (MAP), polyp characteristics and location, participant experience, procedural time and adverse events were measured. Comparison of ADR within the trial with national BowelScope ADR was also undertaken.

RESULTS

3222 participants were randomised (53% male) to receive EAB (n=1610) or SB (n=1612). Baseline demographics were comparable between arms. ADR in the EAB arm was 13.3% and that in the SB arm was 12.2% (p=0.353). No statistically significant differences were found in PDR, MAP, polyp characteristics or location, participant experience, complications or procedural characteristics. ADR in the SB control arm was 3.1% higher than the national ADR.

CONCLUSION

EV did not improve BowelScope ADR when compared with SB. ADR in both arms was higher than the national ADR. Where detection rates are already high, EV is unable to improve detection further.

TRIAL REGISTRATION NUMBERS

NCT03072472, ISRCTN30005319 and CPMS ID 33224.

摘要

目的

腺瘤检出率(ADR)是下消化道内镜的一个重要质量指标。更高的 ADR 与更低的结肠镜检查后结直肠癌发病率相关。英国的软性乙状结肠镜检查(FS)筛查计划(BowelScope)为 55 岁的个体提供一次性 FS。然而,ADR 存在差异。大型研究表明,在结肠镜筛查中使用 Endocuff Vision(EV)可提高 ADR,但在 FS 中尚无研究。我们试图在全国性 FS 筛查人群中测试 EV 对 ADR 的影响。

设计

BowelScope:使用 ENdocuff 优化黏膜异常检测的准确性是一项多中心、随机对照试验,涉及 16 个英国 BowelScope 筛查中心。个体被随机分配到 Endocuff Vision 辅助 BowelScope(EAB)或标准 BowelScope(SB)。测量 ADR、息肉检出率(PDR)、每例平均腺瘤数(MAP)、息肉特征和位置、参与者体验、手术时间和不良事件。还比较了试验内的 ADR 与全国性 BowelScope ADR。

结果

3222 名参与者(53%为男性)被随机分配到 EAB 组(n=1610)或 SB 组(n=1612)。两组的基线人口统计学特征相似。EAB 组的 ADR 为 13.3%,SB 组为 12.2%(p=0.353)。在 PDR、MAP、息肉特征或位置、参与者体验、并发症或手术特征方面,均未发现统计学显著差异。SB 对照组的 ADR 比全国性 ADR 高 3.1%。

结论

与 SB 相比,EV 并未提高 BowelScope 的 ADR。两个臂的 ADR 均高于全国性 ADR。在检测率已经很高的情况下,EV 无法进一步提高检测率。

试验注册号

NCT03072472、ISRCTN30005319 和 CPMS ID 33224。

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