Extract

Background and study aims An endoscopy is a procedure where the inside of the body is examined using an endoscope - a long, thin, flexible tube that has a light source and a video camera at one end. Small samples of tissue (biopsies) are also taken from the lining of the gut. A large number of biopsies are sometimes taken, particularly if a problem is suspected which cannot be seen, such as Barrett’s oesophagus, a condition where the cells of the oesophagus (gullet) grow abnormally which can develop into cancer. Specimens are sent to the laboratory for the pathologists to analyse, and it can take up to 3 weeks to get the result. Devices are being researched that can be used to accurately detect abnormalities within the gut without having to take biopsies. An accurate and effective device would bring huge benefits to patients and the NHS. The aim of this study is to find whether optical biopsy is a quicker and less invasive way to identify abnormalities in the gut. Who can participate? Patients undergoing endoscopy who do or do not have Barrett’s oesophagus What does the study involve? Participants come to the endoscopy unit for the camera test and for biopsies as per normal. Before the procedure they may be asked to give a blood and saliva sample as well as a painless swab taken from the inside of their cheek. During the endoscopy, before the tissue samples are taken, an optical fibre may be placed down the endoscope and a short burst of normal (white) light is passed down the fibre. The light that is reflected back up the fibre is analysed by a computer to obtain diagnostic information (optical biopsy). Routine tissue samples are then taken from the same area. A tissue sample from a nearby area of normal tissue is also taken in order to compare the results from normal and abnormal tissue. Up to four extra tissue samples, up to two cell samples, and a sample of fluid from the gut may also be sent to the pathology laboratory for analysis. The tissue sample results are then compared with the results of the optical biopsies. What are the possible benefits and risks of participating? This study may not directly help the participants, but may help patients in the future by giving an immediate result, both reducing the number of biopsies taken and the waiting time for results. There is no extra risk involved apart from prolonging the endoscopic examination by a few minutes and taking the extra tissue samples, although this is extremely safe. The light measurement only takes a few seconds and the power of light used is so low that it doesn’t affect the participant in any way. The optical biopsy only increases the time of the endoscopy procedure by a few minutes and does not cause any additional discomfort. The taking of tissue samples, brushings and fluid is painless, safe and again only adds minutes to the procedure. Where is the study run from? University College London Hospitals NHS Foundation Trust (UK) When is the study starting and how long is it expected to run for? March 2008 to March 2017 Who is funding the study? University College London (UK) Who is the main contact? Dr Sarah Jevons

Inclusion criteria

• Barrett's oesophagus, dysplasia, aneuploidy or other molecular abnormalities and oesophageal adenocarcinoma

Links

• isrctn