Advanced Endoscopic Imaging in Colonoscopy

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective Randomized Clinical Trial to Assess the Utility of Advanced Endoscopic Imaging and the Impact of New Technologies on Quality in Colonic Examinations

Conditions
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Polyps, Neoplasms

Intervention / Treatment
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* Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)
* Device: Conventional colonoscopy (Olympus CF-H180DL)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Innovative colonoscopy<br>Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus) | Device: Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)<br>* NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.<br>|
| Active Comparator: Conventional colonoscopy<br>Conventional colonoscopy performed without innovative techniques assessed in this study. | Device: Conventional colonoscopy (Olympus CF-H180DL)<br>* Conventional colonoscopy performed without innovative techniques used in experimental arm.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic accuracy of innovative colonoscopy | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total examination time | Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy. | 8-20 minutes | 
| Cecal intubation time | Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot. | 5-15 minutes | 
| Pain intensity (VAS scale) | 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. | immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Narrow Band Imaging, Colorectal Cancer Screening, Colonoscopy, Responsive Insertion Technology, Near Focus