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


Journal

Gut
ISSN: 1468-3288
Titre abrégé: Gut
Pays: England
ID NLM: 2985108R

Informations de publication

Date de publication:
02 2019
Historique:
received: 19 07 2017
revised: 12 12 2017
accepted: 14 12 2017
pubmed: 25 1 2018
medline: 19 1 2019
entrez: 25 1 2018
Statut: ppublish

Résumé

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). 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. 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. EV significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection. NCT02552017, Results; ISRCTN11821044, Results.

Identifiants

pubmed: 29363535
pii: gutjnl-2017-314889
doi: 10.1136/gutjnl-2017-314889
pmc: PMC6352411
doi:

Banques de données

ISRCTN
['ISRCTN11821044']
ClinicalTrials.gov
['NCT02552017']

Types de publication

Comparative Study Journal Article Multicenter Study Randomized Controlled Trial Research Support, Non-U.S. Gov't

Langues

eng

Sous-ensembles de citation

IM

Pagination

280-288

Informations de copyright

© 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.

Déclaration de conflit d'intérêts

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.

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Auteurs

Wee Sing Ngu (WS)

Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.

Roisin Bevan (R)

Department of Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Stockton, UK.

Zacharias P Tsiamoulos (ZP)

Department of Gastroenterology, St Mark's Hospital, London, UK.

Paul Bassett (P)

Statsconsultancy Ltd, Bucks, UK.

Zoë Hoare (Z)

North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.

Matthew D Rutter (MD)

Department of Gastroenterology, North Tees and Hartlepool NHS Foundation Trust, Stockton, UK.

Gayle Clifford (G)

Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.

Nicola Totton (N)

North Wales Organisation for Randomised Trials in Health, Bangor University, Bangor, UK.

Thomas J Lee (TJ)

Department of Gastroenterology, Northumbria NHS Trust, North Tyneside, UK.

Arvind Ramadas (A)

Department of Gastroenterology, South Tees Hospitals NHS Foundation Trust, Middlesbrough, UK.

John G Silcock (JG)

Department of Gastroenterology, County Durham and Darlington NHS Foundation Trust, Durham, UK.

John Painter (J)

Department of Gastroenterology, City Hospitals Sunderland NHS Foundation Trust, Sunderland, UK.

Laura J Neilson (LJ)

Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.

Brian P Saunders (BP)

Department of Gastroenterology, St Mark's Hospital, London, UK.

Colin J Rees (CJ)

Department of Gastroenterology, South Tyneside NHS Foundation Trust, South Shields, UK.
Northern Institute for Cancer Research, Newcastle University, Newcastle, UK.

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