Comparative Study of Colon Capsule and Virtual Colonoscopy (VICOCA)

Summary Colorectal cancer (CRC) represents the second leading cause of cancer deaths in Spain (11,000 deaths per year). Screening of the population over 50 years of age with no significant history (intermediate risk) is recommended, but which screening method is best for promoting adherence in this type of patient has not been well established. There are currently two screening methods that are less invasive than conventional colonoscopy and seem to have higher sensitivity than the test for faecal occult blood (FOBT). These two methods are the colon capsule, which consists in ingesting a capsule that takes photographs of the colon, and virtual colonoscopy, which is a radiological technique. Objectives: 1. To demonstrate that virtual colonoscopy and colon capsule are effective CRC screening techniques in the intermediate risk population, with diagnostic rates comparable to conventional colonoscopy (concordance). 2. To compare the diagnostic rates of the colon capsule and virtual colonoscopy with respect to the size and characteristics of the lesions visualised. 3. To compare the participation rates for each screening strategy and identify the factors that influence participation (individual, family, and socioeconomic factors as well as those relating to the doctor).

Sex

All

Minimum age

50 Years

Maximum age

69 Years

Inclusion Criteria:

The main objective in this study is compare two non-invasive techniques in the study of colorectal cancer. When we calculate the sample size we observed that we need more than 1000 patients per group. In this moment this study is very expensive and it is not feasible. Our proposal is include population with a higher prevalence of lesions: individuals with positive FIT (fecal immunochemical test) in which the prevalence of lesions is 60%. In this case, sample size is reduced considerably.

The eligible population will be men and women, 50-69 years old, with no known risk factors and positive FIT.

Exclusion Criteria:

1. Individuals who have symptoms suggestive of colorectal disease (rectorrhagia, change in bowel movement frequency, constitutional syndrome, anaemia).
2. History of inflammatory bowel disease, colorectal polyposis, colorectal adenoma or CRC, and total or partial colectomy.
3. History of familial adenomatous polyposis or other hereditary polyposis syndromes; hereditary colorectal cancer not associated with polyposis (diagnosed by the presence of germinal mutation in the DNA repair genes and/or by fulfilment of the Amsterdam II criteria);
4. Severe co-morbidity that carries a poor short-term prognosis (disease with an average life expectancy of less than 5 years) or a chronic illness that involves significant limitation of physical activity.
5. Contraindication to undergoing colon capsule or virtual colonoscopy.

• DERIVEDGonzalez-Suarez B, Pages M, Araujo IK, Romero C, Rodriguez de Miguel C, Ayuso JR, Pozo A, Vila-Casadesus M, Serradesanferm A, Gines A, Fernandez-Esparrach G, Pellise M, Lopez-Ceron M, Flores D, Cordova H, Sendino O, Grau J, Llach J, Serra-Burriel M, Cardenas A, Balaguer F, Castells A. Colon capsule endoscopy versus CT colonography in FIT-positive colorectal cancer screening subjects: a prospective randomised trial-the VICOCA study. BMC Med. 2020 Sep 18;18(1):255. doi: 10.1186/s12916-020-01717-4. PMID 32943059