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BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (B-ADENOMA)

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ClinicalTrials.gov Identifier: NCT03072472
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : September 6, 2018
Sponsor:
Collaborators:
ARC Medical Design Ltd
Norgine
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
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 Device: Endocuff Vision Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3221 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Actual Study Start Date : February 14, 2017
Actual Primary Completion Date : February 13, 2018
Actual Study Completion Date : February 13, 2018

Arm Intervention/treatment
Experimental: Endocuff-assisted Flexible Sigmoidoscopy
Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
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.

No Intervention: Standard Flexible Sigmoidoscopy
Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope



Primary Outcome Measures :
  1. Adenoma Detection Rate [ Time Frame: Day of procedure ]
    Proportion of examinations expressed as a percentage where at least one adenoma is found


Secondary Outcome Measures :
  1. Mean adenomas detected per procedure [ Time Frame: Day of procedure ]
    Number of adenomas found in each procedure

  2. Rate of cuff exchange [ Time Frame: Day of procedure ]
    How often the cuff is removed

  3. Non-inferiority of complete withdrawal time in procedures where no polyps are detected [ Time Frame: Day of procedure ]
    Length of procedure in minutes and seconds

  4. Compare overall procedure time between groups [ Time Frame: Day of procedure ]
    Length of procedure in minutes and seconds

  5. Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation). [ Time Frame: Day of procedure ]
    Proportion of examinations expressed as a percentage where at least one adenoma is found

  6. Compare the rate of discovered cancers between groups [ Time Frame: On histology check 48-72 hours post procedure ]
    Number of cancers found

  7. Examination extent between groups based on presumed anatomical location with a straight endoscope [ Time Frame: Day of procedure ]
    Anatomical location

  8. Examination extent between groups based on distance of insertion in centimetres with a straight endoscope [ Time Frame: Day of procedure ]
    Depth of insertion in centimetres

  9. Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort [ Time Frame: Day of procedure ]
    Numerical 4 point patient comfort score

  10. 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. [ Time Frame: Day of procedure ]
    Number of additional colonoscopies required

  11. 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. [ Time Frame: 18 months ]
    Proportion of examinations expressed as a percentage where at least one adenoma is found

  12. Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used. [ Time Frame: 18 months ]
    Proportion of examinations expressed as a percentage where at least one adenoma is found



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Ages Eligible for Study:   55 Years to 61 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03072472


Locations
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United Kingdom
South Tyneside NHS Foundation Trust
South Shields, Tyne And Wear, United Kingdom, NE34 0PL
Bolton NHS Foundation Trust
Bolton, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Cheltenham, United Kingdom, GL53 7AN
Dorset Healthcare University NHS Trust
Dorchester, United Kingdom
County Durham and Darlington NHS Foundation Trust
Durham, United Kingdom, DH1 5TW
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, United Kingdom, LA9 7RG
Kettering General Hospital NHS Trust
Kettering, United Kingdom, NN16 8UZ
North West London Hospitals NHS Trust
London, United Kingdom, HA1 3UJ
Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom, NE29 8NH
Oxford Health NHS Trust
Oxford, United Kingdom, OX3 9DU
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Pennine Acute Hospitals NHS Trust
Rochdale, United Kingdom, OL12 0NB
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S5 7AU
North Tees and Hartlepool NHS Trust
Stockton on Tees, United Kingdom, TS19 8PE
West Hertfordshire Hospitals NHS Trust
Watford, United Kingdom
The Royal Wolverhamptom NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Sponsors and Collaborators
South Tyneside and Sunderland NHS Foundation Trust
ARC Medical Design Ltd
Norgine
Investigators
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Principal Investigator: Colin J Rees, MBBS MRCP FRCP South Tyneside and Sunderland NHS Foundation Trust

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Responsible Party: South Tyneside and Sunderland NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03072472     History of Changes
Other Study ID Numbers: B-ADENOMA
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: September 6, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Tyneside and Sunderland NHS Foundation Trust:
Colorectal Cancer
Endoscopy
Screening
Colonic Adenoma
Adenoma Detection Rate
Endocuff
Endocuff Vision
Additional relevant MeSH terms:
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Adenoma
Colorectal Neoplasms
Digestive System Neoplasms
Gastrointestinal Neoplasms
Intestinal Neoplasms
Neoplasms, Glandular and Epithelial
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases