BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Colorectal Neoplasms Clinical Trial

— B-ADENOMA  

Official title:

BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072472
• Other study ID #: B-ADENOMA
• Status: Completed
• Phase: N/A
• Start date: February 14, 2017
• Est. completion date: February 13, 2018

Study information

• Verified date: September 2018
• Source: South Tyneside NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3221
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 61 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colonic Diseases
• Colonic Polyp
• Colonic Polyps
• Colorectal Neoplasms
• Digestive Disease
• Digestive System Diseases
• Digestive System Neoplasms
• Gastrointestinal Diseases
• Gastrointestinal Neoplasms
• Intestinal Diseases
• Intestinal Neoplasms
• Intestinal Polyps
• Neoplasia GI
• Neoplasms
• Neoplasms, Glandular and Epithelial
• Pathological Conditions, Anatomical
• Polyps
• Rectal Diseases

Intervention

Device:
• Endocuff Vision
The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.

Locations

Country	Name	City	State
United Kingdom	Bolton NHS Foundation Trust	Bolton
United Kingdom	Gloucestershire Hospitals NHS Foundation Trust	Cheltenham
United Kingdom	Dorset Healthcare University NHS Trust	Dorchester
United Kingdom	County Durham and Darlington NHS Foundation Trust	Durham
United Kingdom	University Hospitals of Morecambe Bay NHS Foundation Trust	Kendal
United Kingdom	Kettering General Hospital NHS Trust	Kettering
United Kingdom	North West London Hospitals NHS Trust	London
United Kingdom	Northumbria Healthcare NHS Foundation Trust	North Shields
United Kingdom	Oxford Health NHS Trust	Oxford
United Kingdom	Portsmouth Hospitals NHS Trust	Portsmouth
United Kingdom	Pennine Acute Hospitals NHS Trust	Rochdale
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield
United Kingdom	South Tyneside NHS Foundation Trust	South Shields	Tyne And Wear
United Kingdom	North Tees and Hartlepool NHS Trust	Stockton on Tees
United Kingdom	West Hertfordshire Hospitals NHS Trust	Watford
United Kingdom	The Royal Wolverhamptom NHS Trust	Wolverhampton

Sponsors (3)

Lead Sponsor	Collaborator
South Tyneside NHS Foundation Trust	ARC Medical Design Ltd, Norgine

Country where clinical trial is conducted

United Kingdom, 

Outcome

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