Colon capsule endoscopy in colorectal cancer screening: a randomised controlled trial

IntroductionThe use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial.Methods and analysisWe will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures.Ethics and disseminationAll participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858).Trial registration detailsThe study has been registered with ClinicalTrials.gov under: NCT04049357.

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Colon capsule endoscopy in colorectal cancer screening: a systematic review

Endoscopy ◽

10.1055/a-1308-1297 ◽

2021 ◽

Author(s):

Fanny E. R. Vuik ◽

Stella A. V. Nieuwenburg ◽

Sarah Moen ◽

Cristiano Spada ◽

Carlo Senore ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Capsule Endoscopy ◽

Detection Rate ◽

Screening Tool ◽

Completion Rates ◽

Crc Screening ◽

Colon Capsule Endoscopy ◽

Screening Population ◽

Colon Capsule

Abstract Introduction Primary colonoscopy and fecal immunochemical test (FIT) are the most commonly used colorectal cancer (CRC) screening modalities. Colon capsule endoscopy (CCE) might be an alternative. Data on the performance of CCE as a CRC screening tool in a screening population remain scarce. This is the first systematic review to provide an overview of the applicability of CCE as a CRC screening tool. Methods A systematic search was conducted of literature published up to September 2020. Studies reporting on CRC screening by second-generation CCE in an average-risk screening population were included. Results 582 studies were identified and 13 were included, comprising 2485 patients. Eight studies used CCE as a filter test after a positive FIT result and five studies used CCE for primary screening. The polyp detection rate of CCE was 24 % – 74 %. For polyps > 6 mm, sensitivity of CCE was 79 % – 96 % and specificity was 66 % – 97 %. For polyps ≥ 10 mm, sensitivity of CCE was 84 % – 97 %, which was superior to computed tomographic colonography (CTC). The CRC detection rate for completed CCEs was 93 % (25/27). Bowel preparation was adequate in 70 % – 92 % of examinations, and completion rates varied from 57 % to 92 %, depending on the booster used. No CCE-related complications were described. Conclusion CCE appeared to be a safe and effective tool for the detection of CRC and polyps in a screening setting. Accuracy was comparable to colonoscopy and superior to CTC, making CCE a good alternative to colonoscopy in CRC screening programs, although completion rates require improvement.

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Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial—the VICOCA study

BMC Medicine ◽

10.1186/s12916-020-01717-4 ◽

2020 ◽

Vol 18 (1) ◽

Cited By ~ 2

Author(s):

Begoña González-Suárez ◽

Mario Pagés ◽

Isis Karina Araujo ◽

Cristina Romero ◽

Cristina Rodríguez de Miguel ◽

...

Keyword(s):

Colorectal Cancer ◽

Capsule Endoscopy ◽

Ct Colonography ◽

Colorectal Neoplasia ◽

Randomised Trial ◽

Predictive Values ◽

Crc Screening ◽

Colon Capsule Endoscopy ◽

Neoplastic Lesions ◽

Colon Capsule

Abstract Background Colon capsule endoscopy (CCE) and CT colonography (CTC) are minimally invasive techniques for colorectal cancer (CRC) screening. Our objective is to compare CCE and CTC for the identification of patients with colorectal neoplasia among participants in a CRC screening programme with positive faecal immunochemical test (FIT). Primary outcome was to compare the performance of CCE and CTC in detecting patients with neoplastic lesions. Methods The VICOCA study is a prospective, single-centre, randomised trial conducted from March 2014 to May 2016; 662 individuals were invited and 349 were randomised to CCE or CTC before colonoscopy. Endoscopists were blinded to the results of CCE and CTC. Results Three hundred forty-nine individuals were included: 173 in the CCE group and 176 in the CTC group. Two hundred ninety individuals agreed to participate: 147 in the CCE group and 143 in the CTC group. In the intention-to-screen analysis, sensitivity, specificity and positive and negative predictive values for the identification of individuals with colorectal neoplasia were 98.1%, 76.6%, 93.7% and 92.0% in the CCE group and 64.9%, 95.7%, 96.8% and 57.7% in the CTC group. In terms of detecting significant neoplastic lesions, the sensitivity of CCE and CTC was 96.1% and 79.3%, respectively. Detection rate for advanced colorectal neoplasm was higher in the CCE group than in the CTC group (100% and 93.1%, respectively; RR = 1.07; p = 0.08). Both CCE and CTC identified all patients with cancer. CCE detected more patients with any lesion than CTC (98.6% and 81.0%, respectively; RR = 1.22; p = 0.002). Conclusion Although both techniques seem to be similar in detecting patients with advanced colorectal neoplasms, CCE is more sensitive for the detection of any neoplastic lesion. Trial registration ClinicalTrials.gov Identifier: NCT02081742. Registered: September 16, 2013.

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Patient Preference for Colon Capsule Endoscopy or Colonoscopy in Population-Based Colorectal Cancer Screening: Interim Analysis of First 39,076 Invitations for Fecal Immunochemical test in Careforcolon2015

10.1055/s-0041-1724500 ◽

2021 ◽

Author(s):

U Deding ◽

T Bjørsum-Meyer ◽

L Kaalby ◽

M Kobaek-Larsen ◽

MK Thygesen ◽

...

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Capsule Endoscopy ◽

Patient Preference ◽

Interim Analysis ◽

Population Based ◽

Colon Capsule Endoscopy ◽

Colon Capsule ◽

Immunochemical Test

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Is PillCam COLON Capsule Endoscopy Ready for Colorectal Cancer Screening? A Prospective Feasibility Study in a Community Gastroenterology Practice

The American Journal of Gastroenterology ◽

10.1038/ajg.2008.163 ◽

2009 ◽

Vol 104 (4) ◽

pp. 848-854 ◽

Cited By ~ 44

Author(s):

Andreas Sieg ◽

Kilian Friedrich ◽

Ulla Sieg

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Feasibility Study ◽

Capsule Endoscopy ◽

Colon Capsule Endoscopy ◽

Colon Capsule

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Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2017.05.023 ◽

2018 ◽

Vol 87 (3) ◽

pp. 695-704 ◽

Cited By ~ 6

Author(s):

Andrea Parodi ◽

Geoffroy Vanbiervliet ◽

Cesare Hassan ◽

Xavier Hebuterne ◽

Antonella De Ceglie ◽

...

Keyword(s):

Colorectal Cancer ◽

Capsule Endoscopy ◽

Colorectal Neoplasia ◽

Family Histories ◽

Colon Capsule Endoscopy ◽

Colon Capsule

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Is there a role for colon capsule endoscopy beyond colorectal cancer screening? A literature review

World Journal of Gastroenterology ◽

10.3748/wjg.v20.i36.13006 ◽

2014 ◽

Vol 20 (36) ◽

pp. 13006 ◽

Cited By ~ 7

Author(s):

Konstantinos Triantafyllou

Keyword(s):

Colorectal Cancer ◽

Cancer Screening ◽

Literature Review ◽

Colorectal Cancer Screening ◽

Capsule Endoscopy ◽

Colon Capsule Endoscopy ◽

Colon Capsule

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ID: 3522221 SYSTEMATIC REVIEW AND META-ANALYSIS OF COLON CAPSULE ENDOSCOPY ACCURACY FOR COLORECTAL CANCER SCREENING. AN ALTERNATIVE DURING THE COVID ERA?

Gastrointestinal Endoscopy ◽

10.1016/j.gie.2021.03.253 ◽

2021 ◽

Vol 93 (6) ◽

pp. AB100

Author(s):

Marianny Sulbaran ◽

Wanderley M. Bernardo ◽

Leonardo A. Bustamante-Lopez ◽

Christiano M. Sakai ◽

Paulo Sakai ◽

...

Keyword(s):

Colorectal Cancer ◽

Systematic Review ◽

Cancer Screening ◽

Colorectal Cancer Screening ◽

Capsule Endoscopy ◽

Meta Analysis ◽

Colon Capsule Endoscopy ◽

Colon Capsule

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Directly Mailing gFOBT Kits to Previous Responders Being Recalled for Colorectal Cancer Screening Increases Participation

Journal of the Canadian Association of Gastroenterology ◽

10.1093/jcag/gwz012 ◽

2019 ◽

Vol 3 (5) ◽

pp. 197-203

Author(s):

Jill Tinmouth ◽

Jigisha Patel ◽

Peter C Austin ◽

Nancy N Baxter ◽

Melissa C Brouwers ◽

...

Keyword(s):

Colorectal Cancer ◽

Primary Care ◽

Care Provider ◽

Primary Care Provider ◽

Intervention Group ◽

Absolute Difference ◽

Control Group ◽

Fecal Occult Blood ◽

Average Risk ◽

Crc Screening

Abstract Background Colorectal cancer (CRC) screening with guaiac fecal occult blood test (gFOBT) reduces CRC-related death. Average risk individuals should be recalled for screening with gFOBT every 2 years in order to maximize effectiveness. However, adherence with repeated testing is often suboptimal. Our aim was to evaluate whether adding a gFOBT kit to a mailed recall letter improves participation compared with a mailed recall letter alone, among previous responders to a mailed invitation. Methods We conducted a cluster randomized controlled trial, with the primary care provider as the unit of randomization. Eligible patients had completed a gFOBT and tested negative in an earlier pilot study and were now due for recall. The intervention group received a mailed CRC screening recall letter from their primary care provider plus a gFOBT kit (n = 431) while the control group received a mailed CRC screening mailed recall letter alone (n = 452). The primary outcome was the uptake of gFOBT or colonoscopy within 6 months. Results gFOBT uptake was higher in the intervention group (61.3%, n = 264) compared with the control group (50.4%, n = 228) with an absolute difference between the two groups of 10.8% (95% confidence interval [CI]: 1.4 to 20.2%, P = <0.01). Patients in the intervention group were more likely to complete the gFOBT compared with the control group (odds ratio [OR] = 1.4; 95% CI: 1.1 to 1.9). Conclusion Our findings show that adding gFOBT kits to the mailed recall letter increased participation among persons recalled for screening. Nine gFOBT kits would have to be sent by mail in order to screen one additional person.

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