High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

Study Overview
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Brief Summary
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Over the last years a number of new endoscopic imaging modalities have been introduced (high-definition and virtual chromoendoscopy). Given the theoretical advantage of these new imaging techniques, the investigators aimed to investigate their use for the detection of polyps during colonoscopy.

Official Title
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High Definition Endoscopy and Virtual Chromoendoscopy Versus Standard Resolution Endoscopy in Detection of Colon Polyps

Conditions
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Colonic Adenoma

Intervention / Treatment
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* Diagnostic Test: High-definition
* Diagnostic Test: Virtual chromoendoscopy
* Diagnostic Test: Standard


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: referred for colonoscopy signed informed consent Exclusion Criteria: subtotal colectomy known colorectal tumor or polyp prior to colonoscopy genetic predisposition to colon cancer namely FAP, HNPCC, Hyperplastic polyposis syndrome, juvenile polyposis, Peutz-Jeghers syndrome inflammatory bowel disease primary sclerosering cholangitis

Ages Eligible for Study
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Minimum Age: 18 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: Fujinon standard<br> | Diagnostic Test: Standard<br>* Standard colonoscopy<br>|
| Active Comparator: Fujinon HD<br>Fujinon high-definition | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>|
| Active Comparator: Fujinon HD + VC<br>Fujinon high-definition + virtual chromoendoscopy | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>Diagnostic Test: Virtual chromoendoscopy<br>* Virtual chromoendoscopy<br>|
| Active Comparator: Olympus standard<br> | Diagnostic Test: Standard<br>* Standard colonoscopy<br>|
| Active Comparator: Olympus HD<br>Olympus high-definition | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>|
| Active Comparator: Olympus VC<br>Olympus virtual chromoendoscopy | Diagnostic Test: Virtual chromoendoscopy<br>* Virtual chromoendoscopy<br>|
| Active Comparator: Olympus HD + VC<br>Olympus high-definition + virtual chromoendoscopy | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>Diagnostic Test: Virtual chromoendoscopy<br>* Virtual chromoendoscopy<br>|
| Active Comparator: Pentax standard<br> | Diagnostic Test: Standard<br>* Standard colonoscopy<br>|
| Active Comparator: Pentax HD<br>Pentax high-definition | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>|
| Active Comparator: Pentax VC<br>Pentax virtual chromoendoscopy | Diagnostic Test: Virtual chromoendoscopy<br>* Virtual chromoendoscopy<br>|
| Active Comparator: Pentax HD + VC<br>Pentax high-definition + virtual chromoendoscopy | Diagnostic Test: High-definition<br>* High-definition colonoscopy<br>Diagnostic Test: Virtual chromoendoscopy<br>* Virtual chromoendoscopy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | Percentage of colonoscopies with detection of 1 or more adenomas. ADR is a well-established quality indicator in colonoscopy in the prevalence of adenomas detected (ADR) as recommended by American Society for Gastrointestinal Endoscopy (ASGE)/American College of Gastroenterology Task Force (ACGTF) and European Society of Gastrointestinal Endoscopy (ESGE). Guidelines stipulate to use ADR as main quality indicator in colonoscopy. | 7-10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adenomas | Adenoma per colonoscopy rate (APCR) | 7-10 days | 
| Type of adenomas | Subtypes of adenomas: tubular adenomas, tubulovillous adenomas, sessile serrated adenomas and adenocarcinomas | 7-10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, High-definition endoscopy, Virtual chromoendoscopy, Adenoma detection rate (ADR)