Endoscopy Research at Leeds
Leeds has a long tradition of endoscopy based research and clinical trials and there are several trials currently underway.
Conducting research is the only way to improve endoscopy techniques and delivery, thereby improving clinical practice. It is widely considered that departments that take part in research generally provide the highest quality care overall. [NIHR]
Clinical trials involving endoscopy can be those that are primarily focussed on endoscopy or when endoscopy is part of a trail evaluating another treatment, for example inflammatory bowel disease drugs.
You might be approached by a Research Investigator (usually a Doctor or Nurse) to take part in a research study. We would encourage you to ask if there are any trials that might be suitable for you to take part in.
You will always be given full information about any research study and given the opportunity to ask any questions you may have. Participation in a research project always involves signing a consent form that has been reviewed by an external ethics committee. Central to participation in any research project is the ability for anyone to stop involvement if they so wish at any time and for any reason with any effect on clinical care.
If you are interested in taking part in any of the ongoing clinical trials listed here please contact the endoscopy unit or speak to the nursing staff or endoscopist who will be doing your procedure.
Multi-Centre Trials through the UK Clinical Research Network (UKCRN)
The Clinical Research Network is the part of the NHS that supports clinical research studies. Supported studies are often open in multiple sites across the country.
- ENDCAP-C: Enhanced Neoplasia Detection and Cancer Prevention in Chronic Colitis (ENDCaP-C): A Multicentre test accuracy study (local lead: Venkat Subramanian) Status: in follow up phase
This study uses biopsy samples routinely collected during colonoscopy in patients with inflammatory bowel disease who are undergoing surveillance for early detection of colon cancer. The researchers are attempting to check if a panel of genetic markers they have developed are accurate in identifying patients at increased risk of developing cancer.
- RADIOCYST trial - Pancreatic cysts are pockets of fluid that can sometimes form in the pancreas, and could become cancerous. They often don’t cause any symptoms, and are usually monitored with check-ups involving MRI or CT scans. People with these type of cysts might need surgery and long-term check-ups.
The RADIOCYST trial is looking at treating cysts in the pancreas with a new type of treatment called endoscopic ultrasound-guided radiofrequency ablation (EUS-RFA).
Researchers will use an endoscopic ultrasound scan to create images of the inside of the body to guide the radiofrequency ablation (RFA). RFA works by passing electrical currents through a thin probe (electrode), which is passed through a needle into your pancreas. The electrical current destroys the cyst. The RADIOCYST trial wants to find out if RFA is a safe and effective way of treating people with cysts that could become cancerous. Researchers are also looking at whether it could replace the need for long-term check-ups or surgery. Leeds is one of the centres which is enrolling patients into this multicentre trial.
Local Endoscopy studies at Leeds
In addition to Clinical Research Network studies, many of the Consultants in Leeds run their own projects that are often run by medical students and trainee doctors as part of their training
- High definition versus High definition with chromoendoscopy in the detection of dysplasia in ulcerative colitis (PI: Venkat Subramanian). Status: Trial completed.
The researchers compared the ability of the latest generation high definition endoscopes in detecting early cancer in patients with inflammatory bowel disease and found that using dye spraying (where a blue dye is sprayed on the lining of the bowel as the colonoscope is pulled out) improved the detection rate of early cancer.
- MORDIS: modified resect and discard strategy for characterization of small (< 10 mm) colorectal polyps using the WavStat optical biopsy system. (PI: Venkat Subramanian). Status: Trial completed and results being analysed
In this study the ability of an optical biopsy forceps that used a laser to “read” the polyp and predict if it was benign and precancerous was tested. If successful such a device could provide instant results potentially saving time and money and improve patient care. The study has been completed, preliminary results were encouraging and the final results are now being analysed.
- UNBLIND: Utility of narrow band imaging endoscopy in assessment of colonic inflammation and prediction of outcomes in patients with ulcerative colitis :(PI: Venkat Subramanian): Status: study completed and results being analysed
Narrow band imaging uses a filter to reduce the wavelength of light shone through the endoscope. This is believed to improve the visualization of structures on the surface of the lining of the bowel. The researchers investigated the usefulness of this method in assessing inflammation in patients with colitis. The study has recruited 120 patients and the follow up data is complete. Results are being analysed.
- Dilute versus concentrated dye for surveillance? 0.2% indigocarmine sprayed via a catheter versus 0,03% indigocarmine sprayed via a foot pump for the detection of dysplasia in colitis surveillance (PI: Dr Venkat Subramanian): status: recruiting
Following on from the previous study where the researchers found that dye sparing improved detection of precancerous polyps in patients with colitis undergoing surveillance colonoscopy, they are attempting to clarify which concentration of dye works best and are comparing a dilute and concentrated version. The advantage of using a dilute version is that it could potentially save time as it can be sprayed via a foot pump. Uptake the use of dye spraying is poor around the UK and this could entice more endoscopists to use dye sparing for colitis surveillance.
- Endospray device development: This study is a collaboration with the medical engineering group at the University of Leeds and will attempt to develop a novel spring-loaded syringe driver connected to a multipurpose endoscopic spray catheter with an integrated biopsy forceps to improve the dye spraying procedure and reduce the time taken for this procedure.