Endoscopic Assessment of Polyp Histology

Study Overview
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Brief Summary
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Polyps found during screening colonoscopy have to be removed or at least biopsied. Attempts to save costs include endoscopic assessment of polyps with regards to differential diagnoses between adenomas (which have to be removed) and hyperplastic polyps (could be left in place or removed and not examined histologically). Such a concept would only be feasible if endoscopy can make the differential diagnosis with high accuracy. Such high accuracy rates - between 80% and 95% - have been reported from reference centers with specific scientific interest. The investigators want to test whether these results a) can be reproduced in the private practice setting performing large-volume screening colonoscopies and b) whether latest generation endoscopes provide benefit in terms of better accuracy.

Detailed Description
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Patients undergoing screening colonoscopy will be randomized to the use of two different colonoscopes, namely the latest generation (Pentax iScan, Hi Line) versus the previous generation (Classic Line). On withdrawal, all polyps found will be diagnosed according to their pit pattern (classification scheme mit example images provided) and a differential diagnosis made during the live examination. Pit patterns I/II will be classified as hyperplastic polyps, patterns III-V as adenomas (in a subgroup IV and V will be classified as pre-/malignant). All polyps will be photographed from near distance to allow for later blinded review which will be done on patients with only one polyp (to avoid mix-up of polyps) by 3 examiners and 2 independent hospital experts.

Official Title
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On-Site Endoscopic Prediction of Polyp Histology During Screening Colonoscopy

Conditions
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Colonic Polyps

Intervention / Treatment
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* Device: Latest generation colonoscopy as diagnostic instrument


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients undergoing screening colonoscopy Exclusion Criteria: Missing consent No screening colonoscopy (diagnostic colonoscopy because of symptoms)

Ages Eligible for Study
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Minimum Age: 55 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hi Line<br>This arm is examined with latest generation HDTV colonoscopes | Device: Latest generation colonoscopy as diagnostic instrument<br>* this endoscope is used as compared to an older generations cope (classic line) currently in use<br>* Other names: IScan Colonoscope;|
| No Intervention: Classic Line<br>control group undergoing colonoscopy with older generation scope currently in use in most centers | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy (sensitivity/specificity) of HDTV/iScan image technology (Hi Line) versus conventional colonoscopy (classic Line) in the diagnosis of adenomas versus hyperplastic polyps |  | 14 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of online accuracy during colonoscopy with later blinded image assessment in the differential diagnosis of adenomas versus hyperplastic polyps |  | 14 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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screening colonoscopy, adenoma, hyperplastic polyp, differential diagnosis