Comparison of adenoma miss rate and adenoma detection rate between conventional colonoscopy and colonoscopy with second-generation distal attachment cuff: a multicenter, randomized, back-to-back trial

Kelly E van Keulen; Ioannis S Papanikolaou; Tony W C Mak; Periklis Apostolopoulos; Helmut Neumann; Gabriele Delconte; Manuele Furnari; Yonne Peters; James Y W Lau; Dimitrios Polymeros; Ruud W N Schrauwen; Federica Cavalcoli; Eleni Koukoulioti; Konstantinos Triantafyllou; Joseph C Anderson; Heiko Pohl; Douglas K Rex; Peter D Siersema

doi:10.1016/j.gie.2023.11.017

Comparison of adenoma miss rate and adenoma detection rate between conventional colonoscopy and colonoscopy with second-generation distal attachment cuff: a multicenter, randomized, back-to-back trial

Gastrointest Endosc. 2024 May;99(5):798-808.e3. doi: 10.1016/j.gie.2023.11.017. Epub 2023 Nov 20.

Authors

Kelly E van Keulen¹, Ioannis S Papanikolaou², Tony W C Mak³, Periklis Apostolopoulos⁴, Helmut Neumann⁵, Gabriele Delconte⁶, Manuele Furnari⁷, Yonne Peters¹, James Y W Lau³, Dimitrios Polymeros², Ruud W N Schrauwen⁸, Federica Cavalcoli⁶, Eleni Koukoulioti⁴, Konstantinos Triantafyllou², Joseph C Anderson⁹, Heiko Pohl⁹, Douglas K Rex¹⁰, Peter D Siersema¹¹

Affiliations

¹ Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands.
² Hepatogastroenterology Unit, Second Department of Internal Medicine-Propaedeutic, Medical School, National and Kapodistrian University, Attikon University General Hospital, Athens, Greece.
³ Department of Surgery, Prince of Wales Hospital, Chinese University of Hongkong, Hongkong, China.
⁴ Department of Gastroenterology, 417 Army Veterans Hospital, Athens, Greece.
⁵ Department of Gastroenterology and Hepatology, University Medical Center Mainz, Mainz, Germany.
⁶ Department of Diagnostic Endoscopy and Endoscopic Surgery, Istituto Nazionale Tumori, Milano, Italy.
⁷ Division of Gastroenterology, Department of Internal Medicine, University of Genoa, Genoa, Italy.
⁸ Department of Gastroenterology, Bernhoven Hospital, Uden, The Netherlands.
⁹ Department of Gastroenterology, Gastroenterology, Veterans Affairs Medical Center, White River Junction, Vermont, USA.
¹⁰ Division of Gastroenterology/Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana, USA.
¹¹ Department of Gastroenterology and Hepatology, Radboud University Medical Center, Nijmegen, The Netherlands; Department of Gastroenterology and Hepatology, Erasmus MC-University Medical Center, Rotterdam, The Netherlands. Electronic address: p.siersema@erasmusmc.nl.

PMID: 37993062
DOI: 10.1016/j.gie.2023.11.017

Abstract

Background and aims: Endocuff Vision (Olympus Europe, Hamburg, Germany) has been designed to enhance mucosal visualization, thereby improving detection of (pre-)malignant colorectal lesions. This multicenter, international, back-to-back, randomized colonoscopy trial compared the adenoma detection rate (ADR) and adenoma miss rate (AMR) between Endocuff Vision-assisted colonoscopy (EVC) and conventional colonoscopy (CC).

Methods: Patients aged 40 to 75 years referred for non-immunochemical fecal occult blood test-based screening, surveillance, or diagnostic colonoscopy were included at 10 hospitals and randomized into 4 groups: group 1, 2 × CC; group 2, CC followed by EVC; group 3, EVC followed by CC; and group 4, 2 × EVC. Primary outcomes included ADR and AMR.

Results: A total of 717 patients were randomized, of whom 661 patients (92.2%) had 1 and 646 (90.1%) patients had 2 completed back-to-back colonoscopies. EVC did not significantly improve ADR compared to CC (41.1%; [95% confidence interval (CI), 36.1-46.3] vs 35.5% [95% CI, 30.7-40.6], respectively; P = .125), but EVC did reduce AMR by 11.7% (29.6% [95% CI, 23.6-36.5] vs 17.9% [95% CI, 12.5-23.5], respectively; P = .049). AMR of 2 × CC compared to 2 × EVC was also not significantly different (25.9% [95% CI, 19.3-33.9] vs 18.8% [95% CI, 13.9-24.8], respectively; P = .172). Only 3.7% of the polyps missed during the first procedures had advanced pathologic features. Factors affecting risk of missing adenomas were age (P = .002), Boston Bowel Preparation Scale (P = .008), and region where colonoscopy was performed (P < .001).

Conclusions: Our trial shows that EVC reduces the risk of missing adenomas but does not lead to a significantly improved ADR. Remarkably, 25% of adenomas are still missed during conventional colonoscopies, which is not different from miss rates reported 25 years ago; reassuringly, advanced features were only found in 3.7% of these missed lesions. (Clinical trial registration number: NCT03418948.).

Associated data

ClinicalTrials.gov/NCT03418948