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常规临床实践中小肠结肠息肉的窄带成像光学诊断:检测、检查、表征、切除与丢弃2(DISCARD 2)研究

Narrow band imaging optical diagnosis of small colorectal polyps in routine clinical practice: the Detect Inspect Characterise Resect and Discard 2 (DISCARD 2) study.

作者信息

Rees Colin J, Rajasekhar Praveen T, Wilson Ana, Close Helen, Rutter Matthew D, Saunders Brian P, East James E, Maier Rebecca, Moorghen Morgan, Muhammad Usman, Hancock Helen, Jayaprakash Anthoor, MacDonald Chris, Ramadas Arvind, Dhar Anjan, Mason James M

机构信息

Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.

School of Medicine, Pharmacy and Health, Durham University, Durham, UK.

出版信息

Gut. 2017 May;66(5):887-895. doi: 10.1136/gutjnl-2015-310584. Epub 2016 Apr 19.

Abstract

BACKGROUND

Accurate optical characterisation and removal of small adenomas (<10 mm) at colonoscopy would allow hyperplastic polyps to be left in situ and surveillance intervals to be determined without the need for histopathology. Although accurate in specialist practice the performance of narrow band imaging (NBI), colonoscopy in routine clinical practice is poorly understood.

METHODS

NBI-assisted optical diagnosis was compared with reference standard histopathological findings in a prospective, blinded study, which recruited adults undergoing routine colonoscopy in six general hospitals in the UK. Participating colonoscopists (N=28) were trained using the NBI International Colorectal Endoscopic (NICE) classification (relating to colour, vessel structure and surface pattern). By comparing the optical and histological findings in patients with only small polyps, test sensitivity was determined at the patient level using two thresholds: presence of adenoma and need for surveillance. Accuracy of identifying adenomatous polyps <10 mm was compared at the polyp level using hierarchical models, allowing determinants of accuracy to be explored.

FINDINGS

Of 1688 patients recruited, 722 (42.8%) had polyps <10 mm with 567 (78.5%) having only polyps <10 mm. Test sensitivity (presence of adenoma, N=499 patients) by NBI optical diagnosis was 83.4% (95% CI 79.6% to 86.9%), significantly less than the 95% sensitivity (p<0.001) this study was powered to detect. Test sensitivity (need for surveillance) was 73.0% (95% CI 66.5% to 79.9%). Analysed at the polyp level, test sensitivity (presence of adenoma, N=1620 polyps) was 76.1% (95% CI 72.8% to 79.1%). In fully adjusted analyses, test sensitivity was 99.4% (95% CI 98.2% to 99.8%) if two or more NICE adenoma characteristics were identified. Neither colonoscopist expertise, confidence in diagnosis nor use of high definition colonoscopy independently improved test accuracy.

INTERPRETATION

This large multicentre study demonstrates that NBI optical diagnosis cannot currently be recommended for application in routine clinical practice. Further work is required to evaluate whether variation in test accuracy is related to polyp characteristics or colonoscopist training.

TRIAL REGISTRATION NUMBER

The study was registered with clinicaltrials.gov (NCT01603927).

摘要

背景

在结肠镜检查中准确地对小腺瘤(<10毫米)进行光学特征分析并切除,将使得增生性息肉得以原位保留,且无需组织病理学检查就能确定监测间隔。尽管窄带成像(NBI)在专科实践中较为准确,但在常规临床实践中的表现却鲜为人知。

方法

在一项前瞻性、盲法研究中,将NBI辅助光学诊断与参考标准组织病理学结果进行比较,该研究招募了英国六家综合医院中接受常规结肠镜检查的成年人。参与的结肠镜检查医师(N = 28)使用NBI国际结直肠内镜(NICE)分类法(涉及颜色、血管结构和表面形态)进行培训。通过比较仅有小息肉患者的光学和组织学检查结果,使用两个阈值在患者层面确定检测敏感性:腺瘤的存在和监测需求。使用分层模型在息肉层面比较识别<10毫米腺瘤性息肉的准确性,从而探索准确性的决定因素。

结果

在招募的1688例患者中,722例(42.8%)有<10毫米的息肉,其中567例(78.5%)仅有<10毫米的息肉。通过NBI光学诊断的检测敏感性(腺瘤存在,N = 499例患者)为83.4%(95%CI 79.6%至86.9%),显著低于本研究设定的95%的敏感性(p<0.001)。检测敏感性(监测需求)为73.0%(95%CI 66.5%至79.9%)。在息肉层面进行分析,检测敏感性(腺瘤存在,N = 1620个息肉)为76.1%(95%CI 72.8%至79.1%)。在完全调整分析中,如果识别出两个或更多NICE腺瘤特征,检测敏感性为99.4%(95%CI 98.2%至99.8%)。结肠镜检查医师的专业知识、诊断信心以及高清结肠镜的使用均未独立提高检测准确性。

解读

这项大型多中心研究表明,目前不建议在常规临床实践中应用NBI光学诊断。需要进一步开展工作,以评估检测准确性的差异是否与息肉特征或结肠镜检查医师培训有关。

试验注册号

该研究已在clinicaltrials.gov注册(NCT01603927)。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/cd74/5531217/e7e57ad2dcfe/gutjnl-2015-310584f01.jpg

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