A novel colonoscope with an extra-wide field of view increases polyp detection rate compared with standard colonoscope: Prospective model-based trial

Abstract

Background and study aims Colonoscopy, the gold standard for early detection of colorectal cancer, may miss polyps especially those hidden behind folds. This prospective study compared polyp detection and performance of a novel colonoscope with extra-wide field of view (EFOV) of 230 degrees (partially retrograde) to a standard colonoscope (SC, 170 degrees) in a colon model.

Patients and methods A 3D printed colon model was used featuring 12 polyps placed throughout different colon segments, with several located on the proximal side of haustral folds. Endoscopists were instructed to identify polyps, first inserting the SC immediately followed by the EFOV device, and to place a snare to simulate a polypectomy. A standardized survey was used to record operator impressions.

Results Twenty-nine experienced endoscopists participated in this study. On average, 5.3 vs 9.6 polyps were detected with the standard and EFOV colonoscopes, respectively (P < 0.001). Five of 29 operators (17.2%) detected all 12 polyps with the EFOV device, whereas no operator detected all polyps with the SC. The success rate for snare placement was 100% for both endoscopes with similar times (mean of 14 vs 15 seconds for SC and EFOV, respectively). EFOV handling and optical performance were rated as equally good or better by all endoscopists.

Conclusions Use of a colonoscope with novel optics significantly improved polyp detection compared with a standard colonoscope in this non-randomized model-based study, with favorable performance and usability ratings for the EFOV instrument. Clinical studies are needed to confirm these encouraging preliminary results.

Keywords

Endoscopy Lower GI Tract - Polyps / adenomas / ... - CRC screening - Colorectal cancer

Publikationsverlauf

Eingereicht: 13. Juli 2024

Angenommen nach Revision: 26. September 2024

Accepted Manuscript online:
07. Oktober 2024

Artikel online veröffentlicht:
28. Oktober 2024

• References

• 1 Bretthauer M, Løberg M, Wieszcy P. et al. Effect of colonoscopy screening on risks of colorectal cancer and related death. N Engl J Med 2022; 387: 1547-1556
• 2 US Preventive Services Task Force, Davidson KW, Barry MJ. et al. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA 2021; 325: 1965-1977
• 3 Zhao S, Wang S, Pan P. et al. Magnitude, risk factors, and factors associated with adenoma miss rate of tandem colonoscopy: a systematic review and meta-analysis. Gastroenterology 2019; 156: 1661-1674.e11
• 4 Kaminski MF, Regula J, Kraszewska E. et al. Quality indicators for colonoscopy and the risk of interval cancer. N Engl J Med 2010; 362: 1795-1803
• 5 Robertson DJ, Lieberman DA, Winawer SJ. et al. Colorectal cancers soon after colonoscopy: a pooled multicohort analysis. Gut 2014; 63: 949-956
• 6 Kaminski MF, Thomas-Gibson S, Bugajski M. et al. Performance measures for lower gastrointestinal endoscopy: A European Society of Gastrointestinal Endoscopy (ESGE) quality improvement initiative. United Eur Gastroenterol J 2017; 5: 309-334
• 7 Corley DA, Jensen CD, Marks AR. et al. Adenoma detection rate and risk of colorectal cancer and death. N Engl J Med 2014; 370: 1298-1306
• 8 Gralnek IM, Suissa A, Domanov S. Safety and efficacy of a novel balloon colonoscope: a prospective cohort study. Endoscopy 2014; 46: 883-887
• 9 Shirin H, Shpak B, Epshtein J. et al. G-EYE colonoscopy is superior to standard colonoscopy for increasing adenoma detection rate: an international randomized controlled trial (with videos). Gastrointest Endosc 2019; 89: 545-553
• 10 Konda V, Chauhan SS. ASGE Technology Committee. et al. Endoscopes and devices to improve colon polyp detection. Gastrointest Endosc 2015; 81: 1122-1129
• 11 Leufkens AM, DeMarco DC, Rastogi A. et al. Effect of a retrograde-viewing device on adenoma detection rate during colonoscopy: the TERRACE study. Gastrointest Endosc 2011; 73: 480-489
• 12 Gralnek IM, Siersema PD, Halpern Z. et al. Standard forward-viewing colonoscopy versus full-spectrum endoscopy: an international, multicentre, randomised, tandem colonoscopy trial. Lancet Oncol 2014; 15: 353-360
• 13 Denzer U, Beilenhoff U, Eickhoff A. et al. S2k guideline: quality requirements for gastrointestinal endoscopy, AWMF registry no. 021–022. Z Gastroenterol 2015; 12: E1-E227
• 14 Rembacken B, Hassan C, Rikemann JF. et al. Quality in screening colonoscopy: position statement of the European Society of Gastrointestinal Endoscopy (ESGE). Endoscopy 2012; 44: 957-968
• 15 Hamilton MA, Collings BJ. Determining the appropriate sample size for nonparametric tests for location shift. Technometrics 1991; 33: 327-337
• 16 Hassan C. Real-time computer-aided detection of colorectal neoplasia during colonoscopy: a systematic review and meta-analysis. Ann Intern Med 2023; 176: 1209-1220
• 17 Floer M, Tschaikowski L, Schepke M. et al. Standard versus Endocuff versus cap-assisted colonoscopy for adenoma detection: A randomised controlled clinical trial. United Eur Gastroenterol J 2021; 9: 443-450
• 18 Gralnek IM, Carr-Lock DL, Segol O. et al. Comparison of standard forward-viewing mode versus ultrawide-viewing mode of a novel colonoscopy platform: a prospective, multicenter study in the detection of simulated polyps in an in vitro colon model (with video). Gastrointest Endosc 2013; 77: 472-479
• 19 Hasan N, Gross SA, Gralnek IM. et al. A novel balloon colonoscope detects significantly more simulated polyps than a standard colonoscope in a colon model. Gastrointest Endosc 2014; 80: 1135-1140
• 20 Uraoka T, Tanaka S, Matsumoto T. et al. A novel extra-wide-angle-view colonoscope: a simulated pilot study using anatomic colorectal models. Gastrointest Endosc 2013; 77: 480-483