None listed
Conditions
Brief summary
This study aims to compare a new form of image processing for endoscopy, called Texture and Colour Enhancement Imaging (TXI), with the existing image processing, white light endoscopy (WLE) and Narrow-Band Imaging (NBI) to determine if TXI is better able to detect early cancerous changes in the oesophagus of patients with Barrett's Oesophagus. Who is it for? You may be eligible for this study if you are between 18 and 80 years of age and you are undergoing a scheduled endoscopy for Barrett's oesophagus monitoring or you have been referred for further assessment of dysplasia/early cancer because of long term Barrett's oesophagus. Study details All participants who choose to enrol in this study will be randomly assigned by chance (similar to flipping a coin) to undergo either TXI followed by WLE and NBI imaging during their endoscopy, or to undergo WLE and NBI followed by TXI during their endoscopy. All participants will undergo both imaging processes, only the order will be randomly assigned. During the endoscopy, tissue biopsies will also be taken to check for cancerous or pre-cancerous cells within the oesophageal tissue. The endoscopy procedure is expected to take up to 15 minutes. It is hoped this research will determine whether the new TXI image process is able to detect more pre-cancerous cells than previous forms of endoscopic imaging. This new form of imaging may then be used to improve health outcomes of future patients with Barrett's oesophagus, by detecting potential cancers earlier so that treatment can be most effective.
Interventions
This study will involve the use of the Olympus EVIS X1 endoscopy system. For each patient, the oesophagus will be examined using three endoscopic imaging techniques; TXI; white-light endoscopy (WLE); and narrow-band imaging (NBI). Biopsies will be taken from any suspicious areas noted on each form of imaging, as well as random four-quadrant biopsies. The endoscopies will be performed by an expert interventional endoscopist with more than 10 years of endoscopy experience. Each patient will have o
This study will involve the use of the Olympus EVIS X1 endoscopy system. For each patient, the oesophagus will be examined using three endoscopic imaging techniques; TXI; white-light endoscopy (WLE); and narrow-band imaging (NBI). Biopsies will be taken from any suspicious areas noted on each form of imaging, as well as random four-quadrant biopsies. The endoscopies will be performed by an expert interventional endoscopist with more than 10 years of endoscopy experience. Each patient will have one endoscopy as part of this study, which will be undertaken at a large tertiary teaching hospital. There will be no differences encountered by participants related to the use of the differing imaging modalities as all patients will receive all modalities. There may be a marginally longer duration of endoscopy to a maximum of 2-3 minutes (in addition to the usual 10-15 minutes for endoscopy + biopsy) in order to carefully examine the oesophagus using the additional forms of imaging. All endoscopies will be performed by the study investigators and photographs will be included in the endoscopy reports to ensure adherence to the intervention. In cases where no suspicious areas are detected on imaging, biopsies will be taking in all four quadrants at 2cm intervals throughout the extent of the Barrett's segment as per the Seattle Protocol. The intervention group will have an endoscopic examination of their Barrett's Oesophagus using TXI, followed by WLE and NBI.
Sponsors
Edward Young
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18-80 years undergoing surveillance endoscopy for Barrett's Oesophagus (BE) or whom are referred for further assessment of dysplasia/early cancer in BE. 2. Patients with BE length of at least 1cm. These patients should also be on acid suppressive therapy (Proton Pump Inhibitor at a standard dose for minimum of 4 weeks to prevent inflammation from disrupting interpretation of BE tissue).
Exclusion criteria
1. Inability or refusal to give informed consent. 2. Patients with coagulation disorders. 3. Patients with significant co morbidity, which includes severe heart failure, chronic renal disease, chronic obstructive airways disease. 4. Patients who are pregnant. 5. Patients taking anti-coagulation medication.
Outcome results
None listed