Identification of Extracolonic Pathologies by Computed Tomographic Colonography in Colorectal Cancer Symptomatic Patients.

BACKGROUND & AIMS: Symptoms suggestive of colorectal cancer may originate outside the colorectum. Computed tomographic colonography (CTC) is used to examine the colorectum and abdominopelvic organs simultaneously. We performed a prospective randomized controlled trial to quantify the frequency, nature, and consequences of extracolonic findings. METHODS: We studied 5384 patients from 21 UK National Health Service hospitals referred by their family doctor for the investigation of colorectal cancer symptoms from March 2004 through December 2007. The patients were assigned randomly to groups that received the requested test (barium enema or colonoscopy, n = 3574) or CTC (n = 1810). We determined the frequency and nature of extracolonic findings, subsequent investigations, ultimate diagnosis, and extracolonic cancer diagnoses 1 and 3 years after testing patients without colorectal cancer. RESULTS: Extracolonic pathologies were detected in 959 patients by CTC (58.7%), in 42 patients by barium enema analysis (1.9%), and in no patients by colonoscopy. Extracolonic findings were investigated in 142 patients (14.2%) and a diagnosis was made for 126 patients (88.1%). Symptoms were explained by extracolonic findings in 4 patients analyzed by barium enema (0.2%) and in 33 patients analyzed by CTC (2.8%). CTC identified 72 extracolonic neoplasms, however, barium enema analysis found only 3 (colonoscopy found none). Overall, CTC diagnosed extracolonic neoplasms in 72 of 1634 patients (4.4%); 26 of these were malignant (1.6%). There were significantly more extracolonic malignancies detected than expected 1 year after examination, but these did not differ between patients evaluated by CTC (22.2/1000 person-years), barium enema (26.5/1000 person-years; P = .43), or colonoscopy (32.0/1000 person-years; P = .88). CONCLUSIONS: More than half of the patients with symptoms of colorectal cancer are found to have extracolonic pathologies by CTC analysis. However, the proportion of patients found to have extracolonic malignancies after 1 year of CTC examination is not significantly greater than after barium enema or colonoscopy examinations. International Standard Randomised Controlled Trials no: 95152621.isrctn.com.

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.

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

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 (≥10 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-the rate of additional colonic investigation-by 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.

Patient acceptability and psychologic consequences of CT colonography compared with those of colonoscopy: results from a multicenter randomized controlled trial of symptomatic patients.

PURPOSE: To use a randomized design to compare patients' short- and longer-term experiences after computed tomographic (CT) colonography or colonoscopy. MATERIALS AND METHODS: After ethical approval, the trial was registered. Patients gave written informed consent. Five hundred forty-seven patients with symptoms suggestive of colorectal cancer who had been randomly assigned at a ratio of 2:1 to undergo either colonoscopy (n = 362) or CT colonography (n = 185) received a validated questionnaire to assess immediate test experience (including satisfaction, worry, discomfort, adverse effects) and a 3-month questionnaire to assess psychologic outcomes (including satisfaction with result dissemination and reassurance). Data were analyzed by using Mann-Whitney U, Kruskal-Wallis, and χ(2) test statistics. RESULTS: Patients undergoing colonoscopy were less satisfied than those undergoing CT colonography (median score of 61 and interquartile range [IQR] of 55-67 vs median score of 64 and IQR of 58-70, respectively; P = .008) and significantly more worried (median score of 16 [IQR, 12-21] vs 15 [IQR, 9-19], P = .007); they also experienced more physical discomfort (median score of 39 [IQR, 29-51] vs 35 [IQR, 24-44]) and more adverse events (82 of 246 vs 28 of 122 reported feeling faint or dizzy, P = .039). However, at 3 months, they were more satisfied with how results were received (median score of 4 [IQR, 3-4] vs 3 [IQR, 3-3], P < .0005) and less likely to require follow-up colonic investigations (17 of 230 vs 37 of 107, P < .0005). No differences were observed between the tests regarding 3-month psychologic consequences of the diagnostic episode, except for a trend toward a difference (P = .050) in negative affect (unpleasant emotions such as distress), with patients undergoing CT colonography reporting less intense negative affect. CONCLUSION: CT colonography has superior patient acceptability compared with colonoscopy in the short term, but colonoscopy offers some benefits to patients that become apparent after longer-term follow-up. The respective advantages of each test should be balanced when referring symptomatic patients.

Patient acceptability of CT colonography compared with double contrast barium enema: results from a multicentre randomised controlled trial of symptomatic patients.

OBJECTIVES: To determine patient acceptability of barium enema (BE) or CT colonography (CTC). METHODS: After ethical approval, 921 consenting patients with symptoms suggestive of colorectal cancer who had been randomly assigned and completed either BE (N = 606) or CTC (N = 315) received a questionnaire to assess experience of the clinical episode including bowel preparation, procedure and complications. Satisfaction, worry and physical discomfort were assessed using an adapted version of a validated acceptability scale. Non-parametric methods assessed differences between the randomised tests and the effect of patient characteristics. RESULTS: Patients undergoing BE were significantly less satisfied (median 61, interquartile range [IQR] 54-67 vs. median 64, IQR 56-69; p = 0.003) and experienced more physical discomfort (median 40, IQR 29-52 vs. median 35.5, IQR 25-47; p < 0.001) than those undergoing CTC. Post-test, BE patients were significantly more likely to experience 'abdominal pain/cramps' (68% vs. 57%; p = 0.007), 'soreness' (57% vs. 37%; p < 0.001), 'nausea/vomiting' (16% vs. 8%; p = 0.009), 'soiling' (31% vs. 23%; p = 0.034) and 'wind' (92% vs. 84%; p = 0.001) and in the case of 'wind' to also rate it as severe (27% vs. 15%; p < 0.001). CONCLUSION: CTC is associated with significant improvements in patient experience. These data support the case for CTC to replace BE.

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).

BACKGROUND: Computed tomographic colonography (CTC) is a relatively new diagnostic test that may be superior to existing alternatives to investigate the large bowel. OBJECTIVES: To compare the diagnostic efficacy, acceptability, safety and cost-effectiveness of CTC with barium enema (BE) or colonoscopy. DESIGN: Parallel randomised trials: BE compared with CTC and colonoscopy compared with CTC (randomisation 2 : 1, respectively). SETTING: A total of 21 NHS hospitals. PARTICIPANTS: Patients aged ≥ 55 years with symptoms suggestive of colorectal cancer (CRC). INTERVENTIONS: CTC, BE and colonoscopy. MAIN OUTCOME MEASURES: For the trial of CTC compared with BE, the primary outcome was the detection rate of CRC and large polyps (≥ 10 mm), with the proportion of patients referred for additional colonic investigation as a secondary outcome. For the trial of CTC compared with colonoscopy, the primary outcome was the proportion of patients referred for additional colonic investigation, with the detection rate of CRC and large polyps as a secondary outcome. Secondary outcomes for both trials were miss rates for cancer (via registry data), all-cause mortality, serious adverse events, patient acceptability, extracolonic pathology and cost-effectiveness. RESULTS: A total of 8484 patients were registered and 5384 were randomised and analysed (BE trial: 2527 BE, 1277 CTC; colonoscopy trial: 1047 colonoscopy, 533 CTC). Detection rates in the BE trial were 7.3% (93/1277) for CTC, compared with 5.6% (141/2527) for BE (p = 0.0390). The difference was due to better detection of large polyps by CTC (3.6% vs. 2.2%; p = 0.0098), with no significant difference for cancer (3.7% vs. 3.4%; p = 0.66). Significantly more patients having CTC underwent additional investigation (23.5% vs. 18.3%; p = 0.0003). At the 3-year follow-up, the miss rate for CRC was 6.7% for CTC (three missed cancers) and 14.1% for BE (12 missed cancers). Significantly more patients randomised to CTC than to colonoscopy underwent additional investigation (30% vs. 8.2%; p < 0.0001). There was no significant difference in detection rates for cancer or large polyps (10.7% for CTC vs. 11.4% for colonoscopy; p = 0.69), with no difference when cancers (p = 0.94) and large polyps (p = 0.53) were analysed separately. At the 3-year follow-up, the miss rate for cancer was nil for colonoscopy and 3.4% for CTC (one missed cancer). Adverse events were uncommon for all procedures. In 1042 of 1748 (59.6%) CTC examinations, at least one extracolonic finding was reported, and this proportion increased with age (p < 0.0001). A total of 149 patients (8.5%) were subsequently investigated, and extracolonic neoplasia was diagnosed in 79 patients (4.5%) and malignancy in 29 (1.7%). In the short term, CTC was significantly more acceptable to patients than BE or colonoscopy. Total costs for CTC and colonoscopy were finely balanced, but CTC was associated with higher health-care costs than BE. The cost per large polyp or cancer detected was £4235 (95% confidence interval £395 to £9656). CONCLUSIONS: CTC is superior to BE for detection of cancers and large polyps in symptomatic patients. CTC and colonoscopy detect a similar proportion of large polyps and cancers and their costs are also similar. CTC precipitates significantly more additional investigations than either BE or colonoscopy, and evidence-based referral criteria are needed. Further work is recommended to clarify the extent to which patients initially referred for colonoscopy or BE undergo subsequent abdominopelvic imaging, for example by computed tomography, which will have a significant impact on health economic estimates. TRIAL REGISTRATION: Current Controlled Trials ISRCTN95152621.