Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial

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• 作者：Prof Steve Halligan ; FRCR^a ; ^{s.halligan@ucl.ac.uk} ; Kate Wooldrage ; MSc^b ; Edward Dadswell ; MSci^b ; Ines Kralj-Hans ; PhD^b ; Christian von Wagner ; PhD^a ; Rob Edwards ; PhD^c ; Guiqing Yao ; PhD^d ; Prof Clive Kay ; FRCR^e ; David Burling ; FRCR^f ; Omar Faiz ; FRCS^f ; Julian Teare ; FRCP^g ; Prof Richard J Lilford ; FFPHM^d ; Prof Dion Morton ; FRCS^d ; Prof Jane Wardle ; PhD^a ; Prof Wendy Atkin ; PhD^b ; for the SIGGAR investigators ^&dagger ;
• 刊名：The Lancet
• 出版年：2013
• 出版时间：6-12 April, 2013
• 年：2013
• 卷：381
• 期：9873
• 页码：1185-1193
• 全文大小：240 K

文摘

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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 computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome¡ªdiagnosis of colorectal cancer or large (¡Ý10 mm) polyps¡ªby 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 significantly 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.

Funding

NIHR Health Technology Assessment Programme, NIHR Biomedical Research Centres funding scheme, Cancer Research UK, EPSRC Multidisciplinary Assessment of Technology Centre for Healthcare, and NIHR Collaborations for Leadership in Applied Health Research and Care.