ADENOMA - impact case study

ADENOMA
Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities

Key features

Study dates: 2014 - 2016
Funded by ARC Medical Design Limited
Almost 1,800 patients recruited, with support from the NIHR Clinical Research Network
Study took place at seven sites across the UK
Chief Investigator: Professor Colin Rees, Professor of Gastroenterology at Newcastle University and South Tyneside and Sunderland NHS Foundation Trust

Bowel cancer is common in the UK, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous.

A colonoscopy is considered the gold standard for preventing bowel cancer. It involves using a camera to look inside the bowel, find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. Although experienced endoscopists perform the colonoscopies, polyps can get missed for various reasons including the size, shape and location of the lesions, and many colorectal cancer screening programmes have been proposed to improve adenoma detection rate (ADR).

Improving the ADR and cancer detection through increased colonoscopy performance brings patient benefits, and earlier diagnosis of cancer is also associated with lower healthcare costs (Cancer Research UK 2014).

A new device, called the Endocuff Vision, a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel, has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier.
Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49 per cent to 66 per cent). The ADENOMA study was a larger scale randomized controlled trial to compare colonoscopies performed with and without the device.

Outcomes and findings

The study opened in seven sites across England and successfully recruited almost 1,800 patients ahead of time. Patients were referred to participate in the trial because of symptoms, surveillance or following a positive faecal occult blood test as part of the Bowel Cancer Screening Programme. Almost half of the patients recruited (45 per cent) were recruited via the screening programme.

Patients were randomised to two arms of the trial, to have a colonoscopy performed with the Endocuff Vision attached or to have a standard colonoscopy performed. Patients in the Endocuff Vision arm of the trial, had a higher Adenoma Detection Rate which increased globally from 36.2 per cent to 40.9 per cent (P=0.02). the increase was driven by a 10.8 per cent increase in FOBt-positive screening patients (50.9 per cent vs 61.7 per cent, P<0.001).
There was also an increase in detection of mean adenomas per procedure, sessile serrated polyps, left-sided, diminutive, small adenomas and cancers for Endocuff Vision patients when compared to those in the standard colonoscopy arm. Median intubation was a minute quicker with the device and there was no difference in caecal (the furthest part of the large bowel from the anus) intubation rate or withdrawal time. The ADENOMA trial showed that Endocuff Vision significantly improved ADR in bowel cancer screening patients and should be used to improve colonoscopic detection.

Value to the NHS

The success of the trial led to NHS England announcing Endocuff Vision as one of only four technologies to be fast-tracked into use through NHS England’s Innovation and Technology Payment programme in April 2018.

NICE updated its guidelines for use in June 2019 and NHS trusts across England have significantly increased use of the product.
The Endocuff Vision device has also been adopted internationally and there has been a large rise in the use of the device over the last four years.
In March 2018, South Tyneside NHS Foundation Trust and Academic partners were awarded the Acute Sector Medilink Healthcare Business Award for their collaboration with industry on the ADENOMA and BADENOMA trials.
In November 2018, Endocuff Vision won both a UK Industry Award for collaboration and an AHSN collaboration/innovation award; and in December 2018 it won at The British Healthcare Trades Awards for Best Innovation Developed in Collaboration with the NHS.

The collaborative research utilising Endocuff Vision demonstrates the very best of researchers, patients, academia, industry and the NIHR working in collaboration. Together we have delivered high quality, practice changing research that is having an impact on patient care nationally and internationally. This is exactly how collaborative research should be delivered.

Professor Colin Rees, Chief Investigator on the ADENOMA trial.

The ADENOMA trial was the only study powered to detect a difference in adenoma detection rates and the results showed a statistically significant improvement with Endocuff Vision of almost 11%. The EAC [External Assessment Centre] concluded that ADENOMA was a high-quality study with a low risk of bias. The clinical experts confirmed that the trial accurately represented NHS clinical practice.

NICE Guidelines June 2019

Key publications

BMJ Journals - Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial
PubMed.gov - Improved adenoma detection with Endocuff Vision: the ADENOMA randomised controlled trial
Nice Guidance June 2019