None listed
Conditions
Brief summary
The purpose of this study is to compare dysplasia detection rates of conventional forward-viewing colonoscopy against Full Spectrum Endoscopy (FUSE) colonoscopy in an inflammatory bowel disease (IBD)-dysplasia surveillance population. Who is it for? You may be eligible to join this study if you are aged between 18 to 80 years and are eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration. Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years) Study details All participants in this study will undergo a conventional colonoscopy and a Full Spectrum Endoscopy (FUSE) back-to-back in a single day. The order of the procedures will be randomly allocated, i.e. by chance. Full Spectrum Endoscopy (FUSE) is a new imaging technology that adds two side camera lenses to the right and left sides of the colonoscope to the forward viewing lens. The combination of three lenses delivers a 330 degree panoramic mucosal view as opposed to the 170 degree view from conventional forward viewing colonoscopes. Dysplasia detection rates will be compared between procedures. The safety of both procedures will also be evaluated. The results of this study will help us to determine which method of early detection/screening is the most accurate.
Interventions
Randomized order of colonoscopy type (conventional versus FUSE colonoscopy) to determine the miss rates of colonoscopy type. The intervention is the use of the FUSE colonoscope which is a colonoscope that incorporates 3 cameras on the colonoscope tip to provide a panoramic 330-degree field of view. .The size and function of the FUSE colonoscope is otherwise the same as the conventional colonoscope (control). Both instruments visualise the internal lining of the bowel and permit the identification and removal of neoplasia. All subjects will have both procedures performed back-to-back ("crossover tandem colonoscopy") but the order of the procedure will be randomized. The effect is that the second procedure will determine if lesions were missed during the first procedure, and which colonoscope can identify more neoplasia. Both colonoscopies are expected to be equivalent in duration, taking 15-25 minutes. Quality indicator is that colonoscopy withdrawal should be of at least 6 minutes to improve the chances of not missing pathology. Both colonoscopies are conducted by investigators who are experienced in surveillance colonoscopies and accredited endoscopists. The histopathologists are from the Department of Pathology and familiar with the identification and interpretation of IBD dysplasia. Where dysplasia is found, a second gastrointestinal pathologist will assist with the grading through consensus. Both pathologists are blinded to the order of the colonoscopy (which is coded). There is no need for a wash out, as this is not a drug trial. The second colonoscopy is inserted as soon as the processor is connected and switched on, which usually takes 4-5 minutes. The patient remains under sedation during the intervening period and we wish to keep that as brief as possible.
Sponsors
Study design
Eligibility
Inclusion criteria
18-80 years Eligible for inclusion into the IBD Surveillance Program according to the NHMRC guidelines - that is patients with colitis (at least 1/3 extent of the bowel) of at least 8 years duration. Those with concurrent primary sclerosing cholangitis or prior colonic dysplasia are eligible immediately (rather than at 8 years)
Exclusion criteria
Prior colonoscopy surveillance procedure within the past 12 months (or within 2 years for low-risk cases). Adverse effects or contraindications to methylene blue chromoendoscopy (dye spray into the bowel is standard surveillance procedure during surveillance). Pregnancy Lactation Severe comorbidities Prior colon resection (apart from limited caecal resection as part of ileal resection) Active inflammatory colitis (preventing adequate chromoendoscopy) Unable to complete colonoscopy (failure or poor bowel preparation)