Paggi Silvia1, Radaelli Franco1, Senore Carlo2, Maselli Roberta3, Amato Arnaldo1, Andrisani Gianluca4, Di Matteo Francesco4, Cecinato Paolo5, Grillo Simone5, Sereni Giuliana5, Sassatelli Romano5, Manfredi Guido6, Alicante Saverio6, Buscarini Elisabetta6, Canova Daniele7, Milan Luisa7, Pallini Paolo7, Iwatate Mineo9, Rondonotti Emanuele1, Repici Alessandro2,8, Hassan Cesare9
Gastrointest Endosc. 2020 May14.
Background and aims: Linked-color imaging (LCI), a new image-enhancing technology emphasizing contrast in mucosal color, has been demonstrated to substantially reduce polyp miss-rate as compared with standard White-Light (WL) in tandem colonoscopy studies. Whether LCI increases adenoma detection rate (ADR) remains unclear.
Methods: Consecutive subjects undergoing screening colonoscopy after fecal immunochemical test (FIT) positivity were 1:1 randomized to undergo colonoscopy with LCI or WL, both in high-definition systems. Insertion and withdrawal phases of each colonoscopy were carried out using the same assigned light. Experienced endoscopists from 7 Italian centers participated in the study. Randomization was stratified by gender, age, and screening round. The primary outcome measure was represented by ADR.
Results: Of 704 eligible subjects, 649 (48.9% males, mean age +SD 60.8+7.3 years) were included and randomized to LCI (n=326) or WL (n=323) colonoscopy. The ADR was higher in the LCI (51.8%) than in the WL group (43.7%) (RR, 1.19; 95% CI, 1.01-1.40). The proportions of patients with advanced adenomas and sessile serrated lesions (SSL) were 21.2% and 8.6% in LCI and 18.9% and 5.9% in WL arm, respectively (p=NS for both comparisons). At multivariate analysis, LCI was independently associated with ADR, along with male gender, increasing age and adequate (Boston Bowel Preparation Scale >6) bowel preparation. At per-polyp analysis, the mean+SD number of adenomas per colonoscopy was comparable in the LCI and WL arm, whereas the corresponding figures for proximal adenomas was significantly higher in the LCI group (0.72+1.2 vs 0.55+1.07, p=0.05)
Conclusion: In FIT positive patients undergoing screening colonoscopy, the routine use of LCI significantly increases ADR. [Clinicaltrials.gov no:NCT03690297]
1 Gastroenterology Department, Valduce Hospital, Como, Italy
2 Epidemiology and screening Unit – CPO, University Hospital Città della Salute e della Scienza, Turin, Italy
3 Digestive Endoscopy Unit, Division of Gastroenterology, Humanitas Clinical and Research Center, Rozzano, Milan, Italy
4 Digestive Endoscopy Unit, Campus Bio-Medico, Rome, Italy.
5 Unit of Gastroenterology and Digestive Endoscopy, Azienda USL-IRCCS Reggio Emilia, Reggio Emilia, Italy.
6 Gastroenterology Department, ASST Maggiore Hospital, Crema, Italy
7 Gastroenterology Unit, San Bortolo Hospital, Azienda ULSS n.8 Berica, Vicenza, Italy
8 Humanitas University, Milan, Italy
9 Digestive Endoscopy, Nuovo Regina Margherita Hospital, Rome, Italy.