Clinical trial NCT03072472: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Official title: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Neoplasms
Colonic Polyp
Adenoma
Neoplasia GI
Digestive System Neoplasms
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Digestive Disease
Intestinal Diseases
Colonic Diseases
Rectal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Keywords: Colorectal Cancer
Endoscopy
Screening
Colonic Adenoma
Adenoma Detection Rate
Endocuff
Endocuff Vision
Lead sponsor: South Tyneside and Sunderland NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: ARC Medical Design Ltd
name: Norgine
First posted: 2017-03-07
Enrollment: 3221
Sex: ALL
Minimum age (years): 55
Maximum age (years): 61
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.

Detailed description: Colorectal cancer (CRC) is the fourth most common cancer in the UK with 40,000 new cases diagnosed annually. Most CRCs arise from the adenoma-carcinoma sequence which is a process that can take up to 10 years. Population screening programmes allow for earlier detection and removal of adenomas that may become malignant over time thus reducing CRC mortality. The English Bowel Scope Screening (BSS) programme began in 2013 and invites adults aged 55 and above for a one-off flexible sigmoidoscopy. The aim of the BSS programme is to reduce CRC development via the adenoma-carcinoma sequence through the detection and removal of adenomas from the left side of the colon. A large UK study has shown that offering one-off flexible sigmoidoscopy screening with adenoma clearance to adults aged 55-64 years reduced CRC incidence by 23% and mortality by 31%. Adenoma detection rate (ADR) is the most important marker of mucosal visualisation and is a surrogate marker of high quality colonoscopy. Data from colonoscopy studies have illustrated that a 1% increase in ADR is associated with a 3% decrease in interval colorectal cancer. In the BSS programme, ADR is comparatively lower the that shown in the initial sigmoidoscopy screening trials with a wide variation between endoscopists. Another marker that is often used is adenoma miss rates which also demonstrate a wide variation in clinical practice. Reasons for lesions not being detected at flexible sigmoidoscopy can be extrapolated from colonoscopy data and include; suboptimal technique; shorter withdrawal time; inadequate bowel preparation; presence of flat, depressed or subtle lesions; and the inability to visualise the proximal side of haustral folds, flexures (blind spots) and rectal valves. With the aid of the colonoscopic cuff Endocuff Vision®, the investigators aim to improve visualisation of the colonic mucosa by flattening colonic folds and manipulating them away from the field of forward view the investigators hypothesise that the Endocuff Vision® will improve adenoma detection rates by providing better fold retraction, a wider field of view and better scope tip stabilisation. This clinical randomised study will be conducted in subjects referred and scheduled for screening flexible sigmoidoscopy via the NHS English Bowel Scope Screening (BSS) Programme and will compare Endocuff Vision®-Assisted Flexible Sigmoidoscopy (EAFS) with Standard Flexible Sigmoidoscopy (SFS).

Eligibility criteria: Inclusion Criteria:

1. Age 18 years and over
2. Referral for screening flexible sigmoidoscopy
3. Ability to give informed consent

Exclusion Criteria:

1. Absolute contraindications to flexible sigmoidoscopy
2. Established or suspicion of large bowel obstruction or pseudo-obstruction
3. Known colon cancer or polyposis syndromes
4. Known colonic strictures
5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage)
6. Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal
9. Pregnancy

Primary outcomes:
measure: Adenoma Detection Rate
timeFrame: Day of procedure
Secondary outcomes:
measure: Mean adenomas detected per procedure
timeFrame: Day of procedure
measure: Rate of cuff exchange
timeFrame: Day of procedure
measure: Non-inferiority of complete withdrawal time in procedures where no polyps are detected
timeFrame: Day of procedure
measure: Compare overall procedure time between groups
timeFrame: Day of procedure
measure: Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).
timeFrame: Day of procedure
measure: Compare the rate of discovered cancers between groups
timeFrame: On histology check 48-72 hours post procedure
measure: Examination extent between groups based on presumed anatomical location with a straight endoscope
timeFrame: Day of procedure
measure: Examination extent between groups based on distance of insertion in centimetres with a straight endoscope
timeFrame: Day of procedure
measure: Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort
timeFrame: Day of procedure
measure: Identify any difference in future colonoscopic workload produced by increased ADR in terms of number of patients referred for full colonoscopy between the EAFS and SFS groups.
timeFrame: Day of procedure
measure: Compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR to assess any learning curve effect.
timeFrame: 18 months
measure: Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used.
timeFrame: 18 months
Other outcomes:
Locations:
city: South Shields
country: United Kingdom
facility: South Tyneside NHS Foundation Trust
state: Tyne And Wear
city: Bolton
country: United Kingdom
facility: Bolton NHS Foundation Trust
city: Cheltenham
country: United Kingdom
facility: Gloucestershire Hospitals NHS Foundation Trust
city: Dorchester
country: United Kingdom
facility: Dorset Healthcare University NHS Trust
city: Durham
country: United Kingdom
facility: County Durham and Darlington NHS Foundation Trust
city: Kendal
country: United Kingdom
facility: University Hospitals of Morecambe Bay NHS Foundation Trust
city: Kettering
country: United Kingdom
facility: Kettering General Hospital NHS Trust
city: London
country: United Kingdom
facility: North West London Hospitals NHS Trust
city: North Shields
country: United Kingdom
facility: Northumbria Healthcare NHS Foundation Trust
city: Oxford
country: United Kingdom
facility: Oxford Health NHS Trust
city: Portsmouth
country: United Kingdom
facility: Portsmouth Hospitals NHS Trust
city: Rochdale
country: United Kingdom
facility: Pennine Acute Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust
city: Stockton on Tees
country: United Kingdom
facility: North Tees and Hartlepool NHS Trust
city: Watford
country: United Kingdom
facility: West Hertfordshire Hospitals NHS Trust
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhamptom NHS Trust
Study officials:
affiliation: South Tyneside and Sunderland NHS Foundation Trust
name: Colin J Rees, MBBS MRCP FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD, Verma AM, Lee TJ, Walls M; B-ADENOMA trial group comprises. BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3.