ABSTRACT
BACKGROUND: Colonoscopy screening is underused by first-degree relatives (FDRs) of patients with non-syndromic colorectal cancer (CRC) with screening completion rates below 50%. Studies conducted in FDR referred for screening suggest that fecal immunochemical testing (FIT) was not inferior to colonoscopy in terms of diagnostic yield and tumor staging, but screening uptake of FIT has not yet been tested in this population. In this study, we investigated whether the uptake of FIT screening is superior to the uptake of colonoscopy screening in the familial-risk population, with an equivalent effect on CRC detection. METHODS AND FINDINGS: This open-label, parallel-group, randomized trial was conducted in 12 Spanish centers between February 2016 and December 2021. Eligible individuals included asymptomatic FDR of index cases <60 years, siblings or ≥2 FDR with CRC. The primary outcome was to compare screening uptake between colonoscopy and FIT. The secondary outcome was to determine the efficacy of each strategy to detect advanced colorectal neoplasia (adenoma or serrated polyps ≥10 mm, polyps with tubulovillous architecture, high-grade dysplasia, and/or CRC). Screening-naïve FDR were randomized (1:1) to one-time colonoscopy versus annual FIT during 3 consecutive years followed by a work-up colonoscopy in the case of a positive test. Randomization was performed before signing the informed consent using computer-generated allocation algorithm based on stratified block randomization. Multivariable regression analysis was performed by intention-to-screen. On December 31, 2019, when 81% of the estimated sample size was reached, the trial was terminated prematurely after an interim analysis for futility. Study outcomes were further analyzed through 2-year follow-up. The main limitation of this study was the impossibility of collecting information on eligible individuals who declined to participate. A total of 1,790 FDR of 460 index cases were evaluated for inclusion, of whom 870 were assigned to undergo one-time colonoscopy (n = 431) or FIT (n = 439). Of them, 383 (44.0%) attended the appointment and signed the informed consent: 147/431 (34.1%) FDR received colonoscopy-based screening and 158/439 (35.9%) underwent FIT-based screening (odds ratio [OR] 1.08; 95% confidence intervals [CI] [0.82, 1.44], p = 0.564). The detection rate of advanced colorectal neoplasia was significantly higher in the colonoscopy group than in the FIT group (OR 3.64, 95% CI [1.55, 8.53], p = 0.003). Study outcomes did not change throughout follow-up. CONCLUSIONS: In this study, compared to colonoscopy, FIT screening did not improve screening uptake by individuals at high risk of CRC, resulting in less detection of advanced colorectal neoplasia. Further studies are needed to assess how screening uptake could be improved in this high-risk group, including by inclusion in population-based screening programs. TRIAL REGISTRATION: This trial was registered with ClinicalTrials.gov (NCT02567045).
Subject(s)
Colorectal Neoplasms , Early Detection of Cancer , Humans , Early Detection of Cancer/methods , Colonoscopy/methods , Colorectal Neoplasms/epidemiology , Risk Factors , Siblings , Mass Screening/methodsABSTRACT
BACKGROUND: the Galician Health Service established indications and priority levels (I = fast track, II = preferential, III = normal) for colonoscopy, according to the risk of colorectal cancer and significant colonic lesions detection with access from primary health care. Our aim is to show the results of the implementation. METHODS: we included colonoscopies requested in symptomatic patients from June to October 2012 in a prospective observational cross sectional study. We collected health care level (primary, secondary), priority, appropriateness to the established criteria, wait times (from colonoscopy application and initial consultation) and diagnostic yield for colorectal cancer and/or significant colonic lesion. We compared health care levels in priorities I and II. RESULTS: 425 colonoscopies were included (I = 221, II = 141, III = 63). The appropriateness rate to the protocol was 67.5 %. Priority levels were significantly associated to wait times (days) from application (I = 8.7 ± 8.9, II = 50 + or - 20.3, III = 80.2 + or - 32.2; p < 0.001) and initial consultation (I = 32.2 + or - 38, II = 74.5 + or - 44.2, III = 128.5 + or - 47.4; p < 0.001), and with colorectal cancer (I = 20.1 %, II = 19.1 %, III = 4.8 %, p < 0.001) and significant colonic lesion (I = 35.3 %, II = 34 %, III = 19 %, p = 0.002) detection rates. In priority I and II, 21.8 % of colonoscopies were requested from primary health care. Referral form primary health care reduced wait times from initial consultation to colonoscopy (primary = 29.3 + or - 26, secondary = 55.2 + or - 48.6, p < 0.001). Instead, colorectal cancer (OR 2.41, 95 % CI 1.31-4.42) and significant colonic lesion (OR 1.88, 95 % CI 1.13- 3.15) detection rate was increased. CONCLUSIONS: Galician Health Service priority levels are significantly associated with colorectal cancer and significant colonic lesion detection. Referrals to colonoscopy from primary health care reduce waiting times and increase diagnostic yield.