在結(jié)直腸腫瘤患者的診斷過(guò)程中,，雖然鋇劑灌腸（BE）被廣泛用于結(jié)直腸腫瘤患者的診斷,，但是其準(zhǔn)確性和可接受性還存在爭(zhēng)議。而CT結(jié)腸鏡（CTC）或許是一個(gè)更敏感,、更易于接受的選擇,。本研究旨在比較在有癥狀的患者中，CTC和BE對(duì)結(jié)直腸癌或巨大息肉患者診斷的臨床價(jià)值,。來(lái)自英國(guó)倫敦大學(xué)的Steve Halligan等針對(duì)上述問(wèn)題展開(kāi)深入研究,，結(jié)果發(fā)表在Lancet 2月最新的在線期刊上。
本研究為多中心隨機(jī)研究,，研究納入的受試者為來(lái)自于英國(guó)的21家醫(yī)院的,、癥狀疑似結(jié)直腸癌的患者。符合入組條件的受試者為年齡在55歲及以上,、醫(yī)師意見(jiàn)認(rèn)為適合進(jìn)行結(jié)腸影像學(xué)檢查,。將上述患者按照2:1的比例隨機(jī)分為兩組，分別接受BE或CTC檢查,，根據(jù)患者接受檢查的中心和性別對(duì)患者進(jìn)行分層,。本研究的主要結(jié)局為診斷為結(jié)直腸癌或巨大息肉(≥10 mm)的患者數(shù)目，采用意向治療分析對(duì)研究結(jié)果進(jìn)分析,。本研究是符合國(guó)際標(biāo)準(zhǔn)的臨床隨機(jī)對(duì)照研究,，注冊(cè)號(hào)為95152621,。
共有3838名患者被納入本研究，其中2553人接受BE檢查,，另有1285人接受CTC檢查,。有34名患者撤回了知情同意，最終有2527名受試者接受了BE檢查,，另有1277名患者接受CTC檢查,。與接受BE檢查的患者相比，CTC對(duì)于結(jié)直腸癌和巨大息肉的發(fā)現(xiàn)率顯著增加,，前者為5.6%,，后者為7.3%，差異具有顯著統(tǒng)計(jì)學(xué)意義,。在45名確診為結(jié)直腸癌的患者中,，CTC漏診了3人，在85名確診為結(jié)直腸癌的患者中,，BE漏診了12人,。與BE組的患者相比，在CTC檢查后需要額外檢查的患者的比率更高,，兩者比例分別為23.5%和18.3%,，這主要是因?yàn)镃TC檢查的息肉探查率更高。研究者幾乎沒(méi)有觀察到嚴(yán)重不良反應(yīng)的發(fā)生,。
研究結(jié)果指出,，與BE相比，CTC更敏感,。我們的結(jié)果提示,，對(duì)具有結(jié)直腸癌疑似癥狀的患者而言，推薦首選CTC作為影像學(xué)檢查手段,。（生物谷Bioon.com）
doi:10.1016/
PMC:
PMID:
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.
