Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial

Wee Sing Ngu, Roisin Bevan, Zacharias P Tsiamoulos, Paul Bassett, Zoë Hoare, Matthew D Rutter, Gayle Clifford, Nicola Totton, Thomas J Lee, Arvind Ramadas, John G Silcock, John Painter, Laura J Neilson, Brian P Saunders, Colin J Rees, Wee Sing Ngu, Roisin Bevan, Zacharias P Tsiamoulos, Paul Bassett, Zoë Hoare, Matthew D Rutter, Gayle Clifford, Nicola Totton, Thomas J Lee, Arvind Ramadas, John G Silcock, John Painter, Laura J Neilson, Brian P Saunders, Colin J Rees

Abstract

Objective: Low adenoma detection rates (ADR) are linked to increased postcolonoscopy colorectal cancer rates and reduced cancer survival. Devices to enhance mucosal visualisation such as Endocuff Vision (EV) may improve ADR. This multicentre randomised controlled trial compared ADR between EV-assisted colonoscopy (EAC) and standard colonoscopy (SC).

Design: Patients referred because of symptoms, surveillance or following a positive faecal occult blood test (FOBt) as part of the Bowel Cancer Screening Programme were recruited from seven hospitals. ADR, mean adenomas per procedure, size and location of adenomas, sessile serrated polyps, EV removal rate, caecal intubation rate, procedural time, patient experience, effect of EV on workload and adverse events were measured.

Results: 1772 patients (57% male, mean age 62 years) were recruited over 16 months with 45% recruited through screening. EAC increased ADR globally from 36.2% to 40.9% (P=0.02). The increase was driven by a 10.8% increase in FOBt-positive screening patients (50.9% SC vs 61.7% EAC, P<0.001). EV patients had higher detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers (cancer 4.1% vs 2.3%, P=0.02). EV removal rate was 4.1%. Median intubation was a minute quicker with EAC (P=0.001), with no difference in caecal intubation rate or withdrawal time. EAC was well tolerated but caused a minor increase in discomfort on anal intubation in patients undergoing colonoscopy with no or minimal sedation. There were no significant EV adverse events.

Conclusion: EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection.

Trial registration number: NCT02552017, Results; ISRCTN11821044, Results.

Keywords: colonic adenomas; colonoscopy; colorectal adenomas; colorectal cancer; colorectal cancer screening.

Conflict of interest statement

Competing interests: CJR has received research grants from ARC Medical, Olympus Medical, Aquilant Endoscopy, Norgine and travel grants from Boston Scientific and Cook Medical. He is an advisory board member for Ai4Gi. BPS has received speaker grants from Olympus Medical and research support from Norgine, Aquilant and Diagmed. He is an advisory board member for Creo Medical. ZPT was a non-paid speaker for Norgine Pharmaceutical. He has received research and educational grants from Norgine Pharmaceutical and medical equipment support from Olympus. He holds a Consultant Agreement for Creo Medical.

© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2019. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Figures

Figure 1
Figure 1
Endocuff Vision (personal photograph by author).
Figure 2
Figure 2
Endocuff (personal photograph by author).
Figure 3
Figure 3
Trial profile. EAC, EV-assisted colonoscopy; SC, standard colonoscopy.

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