Comparing CT colonography and flexible sigmoidoscopy: a randomised trial within a population-based screening programme.

Daniele Regge, Gabriella Iussich, Nereo Segnan, Loredana Correale, Cesare Hassan, Arrigo Arrigoni, Roberto Asnaghi, Piero Bestagini, Gianmarco Bulighin, Maria Carla Cassinis, Andrea Ederle, Andrea Ferraris, Giovanni Galatola, Teresa Gallo, Giovanni Gandini, Licia Garretti, Maria Cristina Martina, Daniela Molinar, Stefania Montemezzi, Lia MorraMassimiliano Motton, Pietro Occhipinti, Lucia Pinali, Gian Alberto Soardi, Carlo Senore

Research output: Contribution to journalArticlepeer-review

Abstract

IMPORTANCE AND AIMS: The role of CT colonography (CTC) as a colorectal cancer (CRC) screening test is uncertain. The aim of our trial was to compare participation and detection rate (DR) with sigmoidoscopy (flexible sigmoidoscopy (FS)) and CTC in a screening setting. DESIGN SETTING AND PARTICIPANTS: We conducted two randomised clinical trials (RCTs). (1) Participation RCT: individuals, aged 58 years, living in Turin (Italy), were randomly assigned to be invited to FS or CTC screening; (2) detection RCT: residents in northern Italy, aged 58-60, giving their consent to recruitment, were randomly allocated to CTC or FS. Polyps >/=6 mm at CTC, or 'high-risk' distal lesions at FS, were referred for colonoscopy (TC). MAIN OUTCOME MEASURES: Participation rate (proportion of invitees examined); DR of advanced adenomas or CRC (advanced neoplasia (AN)). RESULTS: Participation was 30.4% (298/980) for CTC and 27.4% (267/976) for FS (relative risk (RR) 1.1; 95% CI 0.98 to 1.29). Among men, participation was higher with CTC than with FS (34.1% vs 26.5%, p=0.011). In the detection RCT, 2673 subjects had FS and 2595 had CTC: the AN DR was 4.8% (127/2673, including 9 CRCs) with FS and 5.1% (133/2595, including 10 CRCs) with CTC (RR 1.08; 95% CI 0.85 to 1.37). Distal AN DR was 3.9% (109/2673) with FS and 2.9% (76/2595) with CTC (RR 0.72; 95% CI 0.54 to 0.96); proximal AN DR was 1.2% (34/2595) for FS vs 2.7% (69/2595) for CTC (RR 2.06; 95% CI 1.37 to 3.10). CONCLUSIONS AND RELEVANCE: Participation and DR for FS and CTC were comparable. AN DR was twice as high in the proximal colon and lower in the distal colon with CTC than with FS. Men were more likely to participate in CTC screening. TRIAL REGISTRATION NUMBER: NCT01739608; Pre-results.
Original languageEnglish
Pages (from-to)1434-1440
Number of pages7
JournalGut
Volume66
Publication statusPublished - Aug 1 2017

Keywords

  • Adenoma/*diagnostic imaging/pathology, Colonic Polyps/*diagnostic imaging, *Colonography, Computed Tomographic, Colorectal Neoplasms/*diagnostic imaging/pathology, Early Detection of Cancer/*methods, Female, Humans, Male, Middle Aged, Patient Acceptance of Health Care/statistics & numerical data, Sex Factors, *Sigmoidoscopy, COLONIC NEOPLASMS, COLORECTAL CANCER SCREENING

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