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

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

0140-6736
1185-1193
Halligan, Steve
28ec1300-90f5-4311-85a5-176237c4191b
Wooldrage, Kate
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Dadswell, Edward
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Kralj-Hans, Ines
51a276e5-d2f5-41d0-883b-83a9f230cd60
von Wagner, Christian
ddadb46d-8ff8-4519-ad5a-4efdf8c01888
Edwards, Rob
bad2f867-6d53-4efd-bd6a-78195df61c06
Yao, Guiqing
d777f84c-cf3d-4fad-bbc1-ea01dec01695
Kay, Clive
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Burling, David
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Faiz, Omar
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Teare, Julian
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Lilford, Richard J.
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Morton, Dion
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Wardle, Jane
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Atkin, Wendy
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Halligan, Steve
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Wooldrage, Kate
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Dadswell, Edward
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Kralj-Hans, Ines
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von Wagner, Christian
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Edwards, Rob
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Yao, Guiqing
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Kay, Clive
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Burling, David
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Faiz, Omar
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Teare, Julian
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Lilford, Richard J.
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Morton, Dion
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Wardle, Jane
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Atkin, Wendy
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Halligan, Steve, Wooldrage, Kate, Dadswell, Edward, Kralj-Hans, Ines, von Wagner, Christian, Edwards, Rob, Yao, Guiqing, Kay, Clive, Burling, David, Faiz, Omar, Teare, Julian, Lilford, Richard J., Morton, Dion, Wardle, Jane and Atkin, Wendy (2013) Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial. The Lancet, 381 (9873), 1185-1193. (doi:10.1016/S0140-6736(12)62124-2). (PMID:23414648)

Record type: Article

Abstract

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-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 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.

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e-pub ahead of print date: 14 February 2013
Published date: 6 April 2013
Organisations: Primary Care & Population Sciences

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Local EPrints ID: 351942
URI: https://eprints.soton.ac.uk/id/eprint/351942
ISSN: 0140-6736
PURE UUID: 831cebc9-e313-401d-b058-6f2ab672249c

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Date deposited: 26 Apr 2013 15:25
Last modified: 05 Oct 2018 12:10

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Contributors

Author: Steve Halligan
Author: Kate Wooldrage
Author: Edward Dadswell
Author: Ines Kralj-Hans
Author: Christian von Wagner
Author: Rob Edwards
Author: Guiqing Yao
Author: Clive Kay
Author: David Burling
Author: Omar Faiz
Author: Julian Teare
Author: Richard J. Lilford
Author: Dion Morton
Author: Jane Wardle
Author: Wendy Atkin

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