Abstract
Colorectal cancer (CRC) screening programs have been implemented to reduce the burden of the disease. When an advanced colonic lesion is detected, clinical practice guidelines recommend endoscopic surveillance with different intervals between explorations. Endoscopic surveillance is producing a considerable increase in the number of colonoscopies, with a limited effect on the CRC incidence. Instead, participation in CRC screening programs based on the fecal immunochemical test (FIT) could be a non-inferior alternative to endoscopic surveillance to reduce 10-year CRC incidence. Based on this hypothesis, we have designed a multicenter and randomized clinical trial within the Spanish population CRC screening programs to compare FIT surveillance with endoscopic surveillance. We will include individuals aged from 50 to 65 years with complete colonoscopy and advanced lesions resected within the CRC screening programs. Patients will be randomly allocated to perform an annual FIT and colonoscopy if fecal hemoglobin concentration is ≥10 µg/g, or to perform endoscopic surveillance. On the basis of the non-superior CRC incidence, we will recruit 1894 patients in each arm. The main endpoint is 10-year CRC incidence and the secondary endpoints are diagnostic yield, participation, adverse effects, mortality and cost-effectiveness. Our results may modify the clinical practice after advanced colonic resection in CRC screening programs.
Highlights
Licensee MDPI, Basel, Switzerland.Colorectal cancer (CRC) is one of the most common malignancies in western countries.About 40,000 new cases of CRC are diagnosed each year in Spain, and 39% of those affected die due to this disease [1,2,3]
After the resection of high-risk adenomas detected within the CRC screening program, the 10-year CRC incidence in patients participating in a CRC screening programs based on annual fecal immunochemical test (FIT) determination is not superior to the incidence in patients undergoing endoscopic surveillance
This trial was designed to evaluate the potential of annual FIT for CRC surveillance of patients with advanced colonic lesions instead of surveillance colonoscopy
Summary
Patients with low-risk lesions have been routinely recommended to return to population screening programs, whereas patients with high-risk lesions are recommended to perform endoscopic surveillance with different intervals between explorations [9,11,12] The implementation of this CRC screening strategy is producing a considerable increase in the number of colonoscopies, with a significant cost to the health system, and consuming a high proportion of the colonoscopy capacity [6]. Other studies show that the British population prefer to perform non-invasive fecal test rather than colonoscopy (60.8% vs 31%) [15] Based on this evidence, we have designed a randomized clinical trial within the population CRC screening programs, comparing FIT surveillance to endoscopic surveillance in patients after advanced lesion resection
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