Inflammatory Bowel Disease, Neoplasms, Polyps
Conditions
Keywords
narrow band imaging, dual focus, responsive insertion technique, scope guide, colonoscopy, colorectal cancer screening
Brief summary
The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination. * Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies * Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.
Detailed description
A total of 600 consecutive patients undergoing screening unsedated colonoscopy 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 acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new 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-HQ190F, NBI + Dual Focus)
NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.
Conventional colonoscopy performed without innovative techniques used in experimental arm.
Sponsors
Specialist Diagnostic and Therapeutic Center MEDICINA
Jagiellonian University
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
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 Sano 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. |
| Coecal intubation time | 5-15 minutes | Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot. |
| Pain intensity (VAS scale) | 0-10 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Youden's index for innovative colonoscopy | 1 year | The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
| Diagnostic odds ratio (DOR) for innovative colonoscopy | 1 year | The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
| Sensitivity of innovative colonoscopy | 1 year | The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software. |
| Likelihood ratio for negative test results (LR-) | 1 year | The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
| Area under the ROC curve (AUC) | 1 year | Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software. |
| Likelihood ratio for positive test results (LR+) | 1 year | The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
| Specificity of innovative colonoscopy | 1 year | The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software. |
| Positive predictive Value (PPV) od innovative colonoscopy | 1 year | The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
| Negative predicting value (NPV) of innovative colonoscopy | 1 year | The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software. |
Countries
Poland
Outcome results
None listed