According to the British Society of Gastroenterology, the burden of gastrointestinal and liver disease is heavy for patients, the NHS, and the economy. Gastrointestinal disease is the third most common cause of death, and the most common cause of hospital admission. The National Institute for Health Research (NIHR) Clinical Research Network is at the forefront of developing cutting edge advances in gastroenterology research that are enabling access to enhanced care and treatment.
Obesity levels in the UK have more than trebled in the last 30 years and, on current estimates, more than half the population could be obese by 2050. Strongly associated with obesity, is the increased susceptibility of developing type 2 diabetes, which currently affects 3.2 million of the UK population and costs the NHS £11 billion a year. Gastric bypass can lead to 60% remission in diabetes but with demand for bariatric surgery outstripping supply there is a greater need to develop non-surgical alternatives to combat the ever rising obesity and diabetes epidemic.
One promising alternative comes in the form of an innovative endoscopic implant: EndoBarrier® by GI Dynamics® Inc. EndoBarrier is a 60cm duodenal bypass sleeve that is endoscopically implanted for a period of up to 12 months into patients who have been diagnosed with type 2 diabetes and obesity. It does not involve any surgery and sometimes patients may go home within hours of the procedure.
The NIHR Clinical Research Network has funded the multi-centred trial being conducted at Imperial College NHS Trust. The NIHR Clinical Research Network has been supporting the recruitment of patients into the EndoBarrier Gastrointestinal Liner Diabetes research from primary care trusts across North West London. This has included liaising with 462 GP practices in order to identify patients who might benefit from this innovative study. There was a strong interest from participants for the study with 225 patients recruited between two sites; Imperial NHS Trust and Southampton University.
The study continues until February 2019 but recruitment has closed, as it follows the patients for a year after removal of the device to see how durable the effect is. Half of those included in the study have had the device implanted and will be removed after a year. Early observations indicate a positive impact on the health of those enrolled in the study with positive changes to their diabetes control and weight loss.
Julian Teare, Professor of Gastroenterology at Imperial Healthcare NHS Trust and the study’s principal investigator, says: “We know that both obesity and diabetes pose a huge burden on our health service, and we were pleased to receive a huge response from the general public when recruitment for the trial commenced. Patients were attracted to the study as the intervention is a removable minimally invasive device that does not require any surgery but that has the potential to improve their diabetes and reduce their weight dramatically.”
The NIHR Clinical Research Network makes it possible for patients and health professionals across England to participate in clinical research studies within the NHS. It provides the infrastructure that allows high quality clinical research funded by clients, research funders and life-sciences industry to be undertaken throughout the NHS. The NIHR Clinical Research Network works with patients and the public to make sure their needs are placed at the heart of all research and providing opportunities for patients to gain earlier access to new and innovative treatments through research participation.
A commercial research project is the MORDIS study – A Multicentre, Open, Prospective Study on Modified Resect and Discard Strategy of Small Colonic lesions. Utilising the latest technology from SpectraScience, the WavSTAT4 Optical Biopsy System is used in the study to predict whether polyps are non-suspect or suspect during a colonoscopy.
Polyps (small new tissue growths) in the colon (lower bowel) are quite common and may be benign (normal or ‘non-suspect’) or adenomatous (cancerous/pre-cancerous or ‘suspect’). Non-suspect polyps would generally not be removed but suspect polyps do require removal. During screening by colonoscopy for diseases of the colon, it can be difficult to tell the difference between the two types, which leads to the removal and subsequent laboratory testing of many tissue samples. This extensive sampling is often impractical, time-consuming and costly.
Preliminary results of studies at St James University Hospital, Leeds, using the Wavstat4 system have found a high sensitivity and negative predictive value of around 96% in predicting the nature of removed polyps. This would mean that the optical biopsy forceps is highly accurate in predicting when a polyp is non-suspect. The use of this device during screening for bowel cancer could reduce the number of polyps removed thereby reducing the time taken for the procedure and subsequent cost savings in laboratory testing of tissue.
In this study, the device was used during routine screening colonoscopy and the predictive results (suspect or non-suspect) were also made using the device. The NIHR Clinical Research Network supported the study at St James’ University Hospital, Leeds, which resulted in the study achieving 122% recruitment to time and target. Delivery of studies to time and target is a key focus for the NIHR Clinical Research Network and is an important factor to the life sciences industry. Our support to this study was vital in achieving this timely result for the sponsor. Final results of the study are now being finalised for publication.
Chief investigator of the study, Dr Venkat Subramanian and Clinical Associate Professor and Honorary Consultant Gastroenterologist at the University of Leeds added: “Further work will be needed to assess potential cost savings for the NHS and how well this technology enables clinicians and endoscopists in diverse settings to set appropriate follow up schedules for patients with colorectal polyps detected during colonoscopy. Further UK trials are also likely to be required to ensure the technology can be used effectively by the different kinds of endoscopy centres that exist in the UK.”
In 2016/17 in England there were 20,792 participants recruited into studies that were Gastroenterology related this is nearly a 5% increase from last year; improved feasibility assessment at sites and monitoring of performance has driven an improvement at delivering studies to time and target. The NIHR Clinical Research Network has played an important part in advances in gastroenterology to ensure that NHS patients in the UK remain at the heart of future research developments.