在结直肠肿瘤患者的诊断过程中,虽然钡剂灌肠(BE)被广泛用于结直肠肿瘤患者的诊断,但是其准确性和可接受性还存在争议。而CT结肠镜(CTC)或许是一个更敏感、更易于接受的选择。本研究旨在比较在有症状的患者中,CTC和BE对结直肠癌或巨大息肉患者诊断的临床价值。来自英国伦敦大学的Steve Halligan等针对上述问题展开深入研究,结果发表在Lancet 2月最新的在线期刊上。
本研究为多中心随机研究,研究纳入的受试者为来自于英国的21家医院的、症状疑似结直肠癌的患者。符合入组条件的受试者为年龄在55岁及以上、医师意见认为适合进行结肠影像学检查。将上述患者按照2:1的比例随机分为两组,分别接受BE或CTC检查,根据患者接受检查的中心和性别对患者进行分层。本研究的主要结局为诊断为结直肠癌或巨大息肉(≥10 mm)的患者数目,采用意向治疗分析对研究结果进分析。本研究是符合国际标准的临床随机对照研究,注册号为95152621。
共有3838名患者被纳入本研究,其中2553人接受BE检查,另有1285人接受CTC检查。有34名患者撤回了知情同意,最终有2527名受试者接受了BE检查,另有1277名患者接受CTC检查。与接受BE检查的患者相比,CTC对于结直肠癌和巨大息肉的发现率显著增加,前者为5.6%,后者为7.3%,差异具有显著统计学意义。在45名确诊为结直肠癌的患者中,CTC漏诊了3人,在85名确诊为结直肠癌的患者中,BE漏诊了12人。与BE组的患者相比,在CTC检查后需要额外检查的患者的比率更高,两者比例分别为23.5%和18.3%,这主要是因为CTC检查的息肉探查率更高。研究者几乎没有观察到严重不良反应的发生。
研究结果指出,与BE相比,CTC更敏感。我们的结果提示,对具有结直肠癌疑似症状的患者而言,推荐首选CTC作为影像学检查手段。(生物谷Bioon.com)
doi:10.1016/
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Computed tomographic colonography versus bariumenema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial
Steve Halligan, Kate Wooldrage, Edward Dadswell, Ines Kralj-Hans, Christian von Wagner, Rob Edwards, Guiqing Yao, Clive Kay, David Burling,Omar Faiz, Julian Teare, Richard J Lilford, Dion Morton, Jane Wardle, Wendy Atkin
Summary:Background Barium enema (BE) is widely available for diagnosis of colorectal cancer despite concerns about its accuracy and acceptability. Computed tomographic colonography (CTC) might be a more sensitive and acceptable alternative. We aimed to compare CTC and BE for diagnosis of colorectal cancer or large polyps in symptomatic patients in clinical practice.
Methods: This pragmatic multicentre randomised trial recruited patients with symptoms suggestive of colorectal cancer from 21 UK hospitals. Eligible patients were aged 55 years or older and regarded by their referring clinician as suitable for radiological investigation of the colon. Patients were randomly assigned (2:1) to BE or CTC by computergenerated random numbers, in blocks of six, stratifi ed by trial centre and sex. We analysed the primary outcome—diagnosis of colorectal cancer or large (≥10 mm) polyps—by intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621.
Findings: 3838 patients were randomly assigned to receive either BE (n=2553) or CTC (n=1285). 34 patients withdrew consent, leaving for analysis 2527 assigned to BE and 1277 assigned to CTC. The detection rate of colorectal cancer or large polyps was signifi cantly higher in patients assigned to CTC than in those assigned to BE (93 [7·3%] of 1277 vs 141 [5·6%] of 2527, relative risk 1·31, 95% CI 1·01–1·68; p=0·0390). CTC missed three of 45 colorectal cancers and BE missed 12 of 85. The rate of additional colonic investigation was higher after CTC than after BE (283 [23·5%] of 1206 CTC patients had additional investigation vs 422 [18·3%] of 2300 BE patients; p=0·0003), due mainly to a higher polyp detection rate. Serious adverse events were rare.
Interpretation: CTC is a more sensitive test than BE. Our results suggest that CTC should be the preferred radiological test for patients with symptoms suggestive of colorectal cancer.