Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial

详细信息    查看全文

• 作者：Prof Wendy Atkin ; PhD^a ; ^{w.atkin@imperial.ac.uk} ; Edward Dadswell ; MSci^a ; Kate Wooldrage ; MSc^a ; Ines Kralj-Hans ; PhD^a ; Christian von Wagner ; PhD^b ; 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^b ; Prof Steve Halligan ; FRCR^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：1194-1202
• 全文大小：244 K

文摘

| Figures/TablesFigures/Tables | ReferencesReferences

Summary

Background

Colonoscopy is the gold-standard test for investigation of symptoms suggestive of colorectal cancer; computed tomographic colonography (CTC) is an alternative, less invasive test. However, additional investigation after CTC is needed to confirm suspected colonic lesions, and this is an important factor in establishing the feasibility of CTC as an alternative to colonoscopy. We aimed to compare rates of additional colonic investigation after CTC or colonoscopy for detection of colorectal cancer or large (¡Ý10 mm) 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 colonoscopy. Patients were randomly assigned (2:1) to colonoscopy or CTC by computer-generated random numbers, in blocks of six, stratified by trial centre and sex. We analysed the primary outcome¡ªthe rate of additional colonic investigation¡ªby intention to treat. The trial is an International Standard Randomised Controlled Trial, number 95152621.

Findings

1610 patients were randomly assigned to receive either colonoscopy (n=1072) or CTC (n=538). 30 patients withdrew consent, leaving for analysis 1047 assigned to colonoscopy and 533 assigned to CTC. 160 (30¡¤0 % ) patients in the CTC group had additional colonic investigation compared with 86 (8¡¤2 % ) in the colonoscopy group (relative risk 3¡¤65, 95 % CI 2¡¤87-4¡¤65; p<0¡¤0001). Almost half the referrals after CTC were for small (<10 mm) polyps or clinical uncertainty, with low predictive value for large polyps or cancer. Detection rates of colorectal cancer or large polyps in the trial cohort were 11 % for both procedures. CTC missed 1 of 29 colorectal cancers and colonoscopy missed none (of 55). Serious adverse events were rare.

Interpretation

Guidelines are needed to reduce the referral rate after CTC. For most patients, however, CTC provides a similarly sensitive, less invasive alternative to colonoscopy.

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.