BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Not Applicable

Completed

• Conditions: Colorectal Neoplasms; Neoplasms, Glandular and Epithelial; Intestinal Diseases; Intestinal Polyps; Neoplasia GI; Polyps; Colonic Polyp; Adenoma; Digestive System Neoplasms; Intestinal Neoplasms
• Interventions: Device: Endocuff Vision

• Registration Number: NCT03072472
• Lead Sponsor: South Tyneside and Sunderland NHS Foundation Trust

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).

Study Timeline

• Study First Submitted: 2017-01-16
• Study Start: 2017-02-14
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-13
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-05
• Last Update Posted: 2018-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3221

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff-assisted Flexible Sigmoidoscopy	Endocuff Vision	Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope

Primary Outcome Measures

Name	Time	Method
Adenoma Detection Rate	Day of procedure	Proportion of examinations expressed as a percentage where at least one adenoma is found

Secondary Outcome Measures

Name	Time	Method
Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used.	18 months	Proportion of examinations expressed as a percentage where at least one adenoma is found
Rate of cuff exchange	Day of procedure	How often the cuff is removed
Non-inferiority of complete withdrawal time in procedures where no polyps are detected	Day of procedure	Length of procedure in minutes and seconds
Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).	Day of procedure	Proportion of examinations expressed as a percentage where at least one adenoma is found
Compare the rate of discovered cancers between groups	On histology check 48-72 hours post procedure	Number of cancers found
Compare overall procedure time between groups	Day of procedure	Length of procedure in minutes and seconds
Examination extent between groups based on distance of insertion in centimetres with a straight endoscope	Day of procedure	Depth of insertion in centimetres
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.	Day of procedure	Number of additional colonoscopies required
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.	18 months	Proportion of examinations expressed as a percentage where at least one adenoma is found
Examination extent between groups based on presumed anatomical location with a straight endoscope	Day of procedure	Anatomical location
Mean adenomas detected per procedure	Day of procedure	Number of adenomas found in each procedure
Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort	Day of procedure	Numerical 4 point patient comfort score

Trial Locations

Locations (16)

Bolton NHS Foundation Trust; 🇬🇧 Bolton, United Kingdom

Oxford Health NHS Trust; 🇬🇧 Oxford, United Kingdom

South Tyneside NHS Foundation Trust; 🇬🇧 South Shields, Tyne And Wear, United Kingdom

University Hospitals of Morecambe Bay NHS Foundation Trust; 🇬🇧 Kendal, United Kingdom

Portsmouth Hospitals NHS Trust; 🇬🇧 Portsmouth, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, United Kingdom

Gloucestershire Hospitals NHS Foundation Trust; 🇬🇧 Cheltenham, United Kingdom

Kettering General Hospital NHS Trust; 🇬🇧 Kettering, United Kingdom

North West London Hospitals NHS Trust; 🇬🇧 London, United Kingdom

Dorset Healthcare University NHS Trust; 🇬🇧 Dorchester, United Kingdom

County Durham and Darlington NHS Foundation Trust; 🇬🇧 Durham, United Kingdom

Pennine Acute Hospitals NHS Trust; 🇬🇧 Rochdale, United Kingdom

North Tees and Hartlepool NHS Trust; 🇬🇧 Stockton on Tees, United Kingdom

The Royal Wolverhamptom NHS Trust; 🇬🇧 Wolverhampton, United Kingdom

West Hertfordshire Hospitals NHS Trust; 🇬🇧 Watford, United Kingdom

Northumbria Healthcare NHS Foundation Trust; 🇬🇧 North Shields, United Kingdom