Clinical trial NCT02552017: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Official title: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyps
Adenoma
Keywords: adenoma detection rate
Endocuff
Endocuff Vision
colonoscopy
bowel cancer screening
bowel cancer
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
First posted: 2015-09-16
Enrollment: 1772
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Detailed description: Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Eligibility criteria: Inclusion Criteria:

1. All patients referred for screening, surveillance, or diagnostic colonoscopy
2. All patients must be able to give informed consent

Exclusion Criteria:

1. Patients with any absolute contraindications to colonoscopy
2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
3. Patients with known colon cancer or polyposis syndromes
4. Patients with known colonic strictures
5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
10. Patients who are attending for a therapeutic procedure or assessment of a known lesion

Primary outcomes:
measure: Adenoma detection rate
timeFrame: 10 months
Secondary outcomes:
measure: Mean adenomas detected per procedure
timeFrame: 10 months
measure: Rate of cuff exchange
timeFrame: 10 months
measure: Effect on duration of caecal intubation rates
timeFrame: 10 months
measure: Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires
timeFrame: 10 months
measure: Increase in surveillance colonoscopies caused by increased adenoma detection rate
timeFrame: 10 months
measure: Number of proximal sessile serrated polyps by histology
timeFrame: 10 months
measure: Polyp location
timeFrame: 10 months
measure: Adenoma detection rate of BCSP and non-BCSP endoscopists
timeFrame: 10 months
measure: Change in adenoma detection rate of each endoscopist during the course of the trial
timeFrame: 10 months
measure: Adenoma detection rate of individual endoscopist before and after trial commencement
timeFrame: 10 months
Other outcomes:
Locations:
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
state: County Durham
city: Stockton-on-Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Foundation Trust
state: County Durham
city: Harrow
country: United Kingdom
facility: St Mark's Hospital and Academic Institute
state: Middlesex
city: Middlesbrough
country: United Kingdom
facility: South Tees Hospitals NHS Foundation Trust
state: North Yorkshire
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
state: Tyne and Wear
city: South Shields
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
state: Tyne and Wear
city: Sunderland
country: United Kingdom
facility: City Hospitals Sunderland NHS Foundation Trust
state: Tyne and Wear
Study officials:
affiliation: South Tyneside and Sunderland NHS Foundation Trust
name: Colin Rees, MBBS, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ngu WS, Bevan R, Tsiamoulos ZP, Bassett P, Hoare Z, Rutter MD, Clifford G, Totton N, Lee TJ, Ramadas A, Silcock JG, Painter J, Neilson LJ, Saunders BP, Rees CJ. Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial. Gut. 2019 Feb;68(2):280-288. doi: 10.1136/gutjnl-2017-314889. Epub 2018 Jan 23.