Neoplasms, Polyps
Conditions
Keywords
Narrow Band Imaging, Colorectal Cancer Screening, Colonoscopy, Responsive Insertion Technology, Near Focus
Brief summary
The aim of the study is to evaluate the usefulness of high-tech endoscopy in clinical practice. The important elements of this evaluation are: * Evaluation of the character of neoplastic lesions in the colon based on different imaging techniques * Verification of the endoscopic image with histopathologic descriptions * Establishing the type of the lesion on the basis of Kudo and NICE classifications * Comparison of the result of histopathological examination with the macroscopic type of the lesion * Determination of the most advanced lesions (MAL) * Comparison of the cecal intubation time * Evaluation of the type of anesthesia used during colonoscopy * Subjective assessment of the severity of pain according to VAS (visual analogue scale) * Comparison of the accuracy of the location of lesions on the basis of endoscopic navigation * Comparison of the total examination time * Comparison of adenoma detection rate
Detailed description
A total of 400 consecutive patients undergoing unsedated colonoscopy as a part of a national colorectal cancer screening program will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions according. to Kudo and NICE classification. Endoscopic biopsy samples will be taken from all lesions and in vivo endoscopic diagnosis will be compared with final histopathological result. Thus, sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, cecal intubation rate and pain intensity (VAS) will be determined. This study will help to establish whether advanced imaging technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.
Interventions
DEVICEInnovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)
NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Sponsors
Specialist Diagnostic and Therapeutic Center MEDICINA
Jagiellonian University
Miroslaw Szura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
40 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* written informed consent * no previous abdominal surgery * no colonoscopy during last 10 years
Exclusion criteria
* age \< 40 and \> 65 years * large bowel resection in history * colonoscopy performed during last 10 years * contraindications for general anaesthesia * ASA \> IV * pregnancy * confirmed neoplastic disease * cirrhosis (Child B or C) or ascites * immunosuppressive therapy or steroids intake * malabsorption syndrome * IBD * GI neoplastic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of innovative colonoscopy | 1 year | Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to NICE and Kudo classification during colonoscopy and results will be compared with histologic examination. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total examination time | 8-20 minutes | Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy. |
| Cecal intubation time | 5-15 minutes | Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot. |
| Pain intensity (VAS scale) | immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure | Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure. |
Countries
Poland
Contacts
Primary ContactMiroslaw Szura, MD, PhD
Backup ContactArtur Pasternak, MD, PhD
Outcome results
None listed