Condition category
Cancer
Date applied
07/07/2004
Date assigned
07/07/2004
Last edited
04/05/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Contact information

Type

Scientific

Primary contact

Dr Steve Halligan

ORCID ID

Contact details

Department of Specialist Radiology
University College Hospital
Level 2 Podium
235 Euston Road
London
NW1 2BU
United Kingdom
+44 (0)20 7380 9010
s.halligan@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 02/02/01

Study information

Scientific title

Computed tomography (CT) colonography, colonoscopy, or barium enema for diagnosis of colorectal cancer in older symptomatic patients

Acronym

SIGGAR1

Study hypothesis

CT colonography (CTC) is a new health technology for examination of the large bowel that is disseminating at a rapid rate, based on results from small trials that suggest that it is as sensitive as colonoscopy for detecting bowel cancer and large polyps but safer and more acceptable to patients. Many advocate using CTC to screening for bowel cancer (notably in the USA where the technique has received considerable media attention) but in the UK it is more likely that it will find a role for detecting bowel cancer in patients who have symptoms.

The symptoms of bowel cancer are very non-specific (e.g. abdominal pain, rectal bleeding, change in bowel habit, etc) and most people who have these symptoms won't have bowel cancer. However, they may still need to see a doctor and undergo a bowel examination in order to exclude the disease. The standard tests for looking at the large bowel are colonoscopy and barium enema. Colonoscopy involves the passage of a thin endoscope around the large bowel with a camera at its tip, looking for cancer. It is expensive, difficult to perform, and occasionally dangerous, especially in older patients. The alternative is barium enema, where the bowel is filled with liquid and x-rays then taken. Barium enema is safer, cheaper, and easier to perform than colonoscopy but misses more cancer. CT colonography is a new test that examines the large bowel using a CT scanning machine. Intriguingly, It also affords the opportunity to look at the organs outside the large bowel, and might thus be able to determine of the patients symptoms are coming from elsewhere. The evidence to date suggests that CTC is as sensitive as colonoscopy for detecting cancer but is also safer. It might therefore have important role in the NHS for rapid, accurate, acceptable, safe, and cost-effective investigation of symptomatic patients.

This trial compares CTC with colonoscopy and barium enema in two parallel, prospective multicentre randomised trials (randomised 2 to 1 in favour of the standard test), with choice of the standard test depending on local factors such as availability and expertise. The detection or exclusion of significant large bowel cancer/polyps will be determined for each of the three tests, including the number and nature of any additional tests required to confidently exclude bowel cancer and the incidence, nature, and significance of incidental disease outside the large bowel detected by CTC. The frequency and nature of procedure-related adverse events will be recorded and psychological effects of each test will be measured using validated questionnaires. Patient specific records of costs and outcomes including influence of having follow-up tests and multiple investigations will be obtained and models developed to compare management plans with outcome cost. We will also use the data collected to populate models that summarise the health effects and costs of these alternative diagnostic approaches in patients of differing ages, risks, and preferences.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/020201
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/50623/PRO-02-02-01.pdf

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Colon cancer

Intervention

CT colonography, barium enema, colonoscopy.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/02/2004

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Individuals with symptoms suggestive of colorectal cancer, aged 55 years or older.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

5,025

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/02/2004

Recruitment end date

01/11/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College Hospital
London
NW1 2BU
United Kingdom

Sponsor information

Organisation

Imperial College London (UK)

Sponsor details

South Kensington Campus
London
SW7 2AZ
United Kingdom

Sponsor type

Government

Website

http://www3.imperial.ac.uk

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2007 results in: http://www.ncbi.nlm.nih.gov/pubmed/17963520
2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/21626363
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22438366
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23414648
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/23414650
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25796362
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26198205

Publication citations

  1. Results

    Halligan S, Lilford RJ, Wardle J, Morton D, Rogers P, Wooldrage K, Edwards R, Kanani R, Shah U, Atkin W, Design of a multicentre randomized trial to evaluate CT colonography versus colonoscopy or barium enema for diagnosis of colonic cancer in older symptomatic patients: the SIGGAR study., Trials, 2007, 8, 32, doi: 10.1186/1745-6215-8-32.

  2. Results

    von Wagner C, Smith S, Halligan S, Ghanouni A, Power E, Lilford RJ, Morton D, Dadswell E, Atkin W, Wardle J, , Patient acceptability of CT colonography compared with double contrast barium enema: results from a multicentre randomised controlled trial of symptomatic patients., Eur Radiol, 2011, 21, 10, 2046-2055, doi: 10.1007/s00330-011-2154-y.

  3. Results

    von Wagner C, Ghanouni A, Halligan S, Smith S, Dadswell E, Lilford RJ, Morton D, Atkin W, Wardle J, , Patient acceptability and psychologic consequences of CT colonography compared with those of colonoscopy: results from a multicenter randomized controlled trial of symptomatic patients., Radiology, 2012, 263, 3, 723-731, doi: 10.1148/radiol.12111523.

  4. Results

    Halligan S, Wooldrage K, Dadswell E, Kralj-Hans I, von Wagner C, Edwards R, Yao G, Kay C, Burling D, Faiz O, Teare J, Lilford RJ, Morton D, Wardle J, Atkin W, , Computed tomographic colonography versus barium enema for diagnosis of colorectal cancer or large polyps in symptomatic patients (SIGGAR): a multicentre randomised trial., Lancet, 2013, 381, 9873, 1185-1193, doi: 10.1016/S0140-6736(12)62124-2.

  5. Results

    Atkin W, Dadswell E, Wooldrage K, Kralj-Hans I, von Wagner C, Edwards R, Yao G, Kay C, Burling D, Faiz O, Teare J, Lilford RJ, Morton D, Wardle J, Halligan S, , Computed tomographic colonography versus colonoscopy for investigation of patients with symptoms suggestive of colorectal cancer (SIGGAR): a multicentre randomised trial., Lancet, 2013, 381, 9873, 1194-1202, doi: 10.1016/S0140-6736(12)62186-2.

  6. Results

    Halligan S, Wooldrage K, Dadswell E, Shah U, Kralj-Hans I, von Wagner C, Faiz O, Teare J, Edwards R, Kay C, Yao G, Lilford RJ, Morton D, Wardle J, Atkin W; SIGGAR investigators, Identification of Extra-colonic Pathologies by Computed Tomographic Colonography in Symptomatic Patients, Gastroenterology, 2015, doi: 10.1053/j.gastro.2015.03.011.

  7. Results

    Halligan S, Dadswell E, Wooldrage K, Wardle J, von Wagner C, Lilford R, Yao GL, Zhu S, Atkin W, Computed tomographic colonography compared with colonoscopy or barium enema for diagnosis of colorectal cancer in older symptomatic patients: two multicentre randomised trials with economic evaluation (the SIGGAR trials), Health Technol Assess, 2015 , 19, 54, 1-134, doi: 10.3310/hta19540.

Additional files

Editorial Notes

04/05/2016: Publication reference added. 15/01/2009: the following changes were made to the trial record: 1. The overall trial end date was changed from 31/01/2009 to 01/11/2007 (end of recruitment). 2. The target number of participants was added. On 25/01/2008 the overall trial start and end dates were changed from 01/10/2003 and 31/03/2007 to 01/02/2004 and 31/01/2009, respectively.