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

Primary Purpose

Colorectal Neoplasms, Colonic Polyp, Adenoma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Endocuff Vision
Sponsored by
South Tyneside and Sunderland NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Colorectal Neoplasms focused on measuring Colorectal Cancer, Endoscopy, Screening, Colonic Adenoma, Adenoma Detection Rate, Endocuff, Endocuff Vision

Eligibility Criteria

55 Years - 61 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • South Tyneside NHS Foundation Trust
  • Bolton NHS Foundation Trust
  • Gloucestershire Hospitals NHS Foundation Trust
  • Dorset Healthcare University NHS Trust
  • County Durham and Darlington NHS Foundation Trust
  • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Kettering General Hospital NHS Trust
  • North West London Hospitals NHS Trust
  • Northumbria Healthcare NHS Foundation Trust
  • Oxford Health NHS Trust
  • Portsmouth Hospitals NHS Trust
  • Pennine Acute Hospitals NHS Trust
  • Sheffield Teaching Hospitals NHS Foundation Trust
  • North Tees and Hartlepool NHS Trust
  • West Hertfordshire Hospitals NHS Trust
  • The Royal Wolverhamptom NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endocuff-assisted Flexible Sigmoidoscopy

Standard Flexible Sigmoidoscopy

Arm Description

Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope

Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope

Outcomes

Primary Outcome Measures

Adenoma Detection Rate
Proportion of examinations expressed as a percentage where at least one adenoma is found

Secondary Outcome Measures

Mean adenomas detected per procedure
Number of adenomas found in each procedure
Rate of cuff exchange
How often the cuff is removed
Non-inferiority of complete withdrawal time in procedures where no polyps are detected
Length of procedure in minutes and seconds
Compare overall procedure time between groups
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).
Proportion of examinations expressed as a percentage where at least one adenoma is found
Compare the rate of discovered cancers between groups
Number of cancers found
Examination extent between groups based on presumed anatomical location with a straight endoscope
Anatomical location
Examination extent between groups based on distance of insertion in centimetres with a straight endoscope
Depth of insertion in centimetres
Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort
Numerical 4 point patient comfort score
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
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
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

Full Information

First Posted
January 16, 2017
Last Updated
September 5, 2018
Sponsor
South Tyneside and Sunderland NHS Foundation Trust
Collaborators
ARC Medical Design Ltd, Norgine
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1. Study Identification

Unique Protocol Identification Number
NCT03072472
Brief Title
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Acronym
B-ADENOMA
Official Title
BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
February 14, 2017 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
South Tyneside and Sunderland NHS Foundation Trust
Collaborators
ARC Medical Design Ltd, Norgine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
3221 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endocuff-assisted Flexible Sigmoidoscopy
Arm Type
Experimental
Arm Description
Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
Arm Title
Standard Flexible Sigmoidoscopy
Arm Type
No Intervention
Arm Description
Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope
Intervention Type
Device
Intervention Name(s)
Endocuff Vision
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adenoma Detection Rate
Description
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time Frame
Day of procedure
Secondary Outcome Measure Information:
Title
Mean adenomas detected per procedure
Description
Number of adenomas found in each procedure
Time Frame
Day of procedure
Title
Rate of cuff exchange
Description
How often the cuff is removed
Time Frame
Day of procedure
Title
Non-inferiority of complete withdrawal time in procedures where no polyps are detected
Description
Length of procedure in minutes and seconds
Time Frame
Day of procedure
Title
Compare overall procedure time between groups
Description
Length of procedure in minutes and seconds
Time Frame
Day of procedure
Title
Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).
Description
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time Frame
Day of procedure
Title
Compare the rate of discovered cancers between groups
Description
Number of cancers found
Time Frame
On histology check 48-72 hours post procedure
Title
Examination extent between groups based on presumed anatomical location with a straight endoscope
Description
Anatomical location
Time Frame
Day of procedure
Title
Examination extent between groups based on distance of insertion in centimetres with a straight endoscope
Description
Depth of insertion in centimetres
Time Frame
Day of procedure
Title
Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort
Description
Numerical 4 point patient comfort score
Time Frame
Day of procedure
Title
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.
Description
Number of additional colonoscopies required
Time Frame
Day of procedure
Title
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.
Description
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time Frame
18 months
Title
Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used.
Description
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
61 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age 18 years and over Referral for screening flexible sigmoidoscopy Ability to give informed consent Exclusion Criteria: Absolute contraindications to flexible sigmoidoscopy Established or suspicion of large bowel obstruction or pseudo-obstruction Known colon cancer or polyposis syndromes Known colonic strictures Known severe diverticular segment (that is likely to impede sigmoidoscope passage) Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis) Patients lacking capacity to give informed consent 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 Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Colin J Rees, MBBS MRCP FRCP
Organizational Affiliation
South Tyneside and Sunderland NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Tyneside NHS Foundation Trust
City
South Shields
State/Province
Tyne And Wear
ZIP/Postal Code
NE34 0PL
Country
United Kingdom
Facility Name
Bolton NHS Foundation Trust
City
Bolton
Country
United Kingdom
Facility Name
Gloucestershire Hospitals NHS Foundation Trust
City
Cheltenham
ZIP/Postal Code
GL53 7AN
Country
United Kingdom
Facility Name
Dorset Healthcare University NHS Trust
City
Dorchester
Country
United Kingdom
Facility Name
County Durham and Darlington NHS Foundation Trust
City
Durham
ZIP/Postal Code
DH1 5TW
Country
United Kingdom
Facility Name
University Hospitals of Morecambe Bay NHS Foundation Trust
City
Kendal
ZIP/Postal Code
LA9 7RG
Country
United Kingdom
Facility Name
Kettering General Hospital NHS Trust
City
Kettering
ZIP/Postal Code
NN16 8UZ
Country
United Kingdom
Facility Name
North West London Hospitals NHS Trust
City
London
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Northumbria Healthcare NHS Foundation Trust
City
North Shields
ZIP/Postal Code
NE29 8NH
Country
United Kingdom
Facility Name
Oxford Health NHS Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Portsmouth Hospitals NHS Trust
City
Portsmouth
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
Pennine Acute Hospitals NHS Trust
City
Rochdale
ZIP/Postal Code
OL12 0NB
Country
United Kingdom
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
North Tees and Hartlepool NHS Trust
City
Stockton on Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
West Hertfordshire Hospitals NHS Trust
City
Watford
Country
United Kingdom
Facility Name
The Royal Wolverhamptom NHS Trust
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32245908
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.
Results Reference
derived

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BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

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