Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Study Overview
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Brief Summary
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The purpose of this study is to compare the accuracy of using different endoscopic imaging technique (white light, white light with near focus, narrow band imaging (NBI), NBI with near focus) for detection of residual neoplastic tissue at site of prior EMR

Detailed Description
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Residual neoplasia after EMR is a common. Optimal surveillance protocols are not clearly defined. There is a need for better imaging modalities to evaluate for residual disease. Suspected residual tissue can be confirmed with repeat colonoscopy or can be empirically treated. However, this can lead to either frequent colonoscopy or overtreatment. This presents more cost and financial burden to the patient. With the introduction of newer colonoscopes that have near focus/zoom capability, it is important to assess whether the near focus technology offers better accuracy for detection of residual neoplastic tissue. With better accuracy to confidently rule out residual neoplasia using newer imaging modality, additional treatment or biopsy at the previous EMR may be avoided. Furthermore, the interval for surveillance colonoscopy can be lengthened.

Official Title
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Diagnostic Accuracy of Using Colonoscope With Near Focus Capability in Detecting Residual Colorectal Neoplastic Tissue After Endoscopic Mucosal Resection (EMR): a Prospective Study

Conditions
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Post-endoscopic Mucosal Resection of Colon Polyps

Intervention / Treatment
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* Device: Olympus CF190 Colonoscope High definition white light
* Device: Olympus CF190 Colonoscope White light with near focus
* Device: Olympus CF190 Colonoscope Narrow band imaging
* Device: Olympus CF190 Colonoscope Narrow band imaging with near focus
* Procedure: Biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Post-EMR follow up at 6-12 months Exclusion Criteria: Non-corrected coagulopathy Pregnancy Breast feeding

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endoscopic scar assessment<br>Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus. | Device: Olympus CF190 Colonoscope High definition white light<br>* Standard endoscopic imaging technique<br>Device: Olympus CF190 Colonoscope White light with near focus<br>* Near focus mode is used to closely examine the area of prior EMR site.<br>Device: Olympus CF190 Colonoscope Narrow band imaging<br>* Narrow band imaging is utilized to examine the area of prior EMR.<br>Device: Olympus CF190 Colonoscope Narrow band imaging with near focus<br>* NBI with near focus to help closely examine the area of prior EMR site.<br>Procedure: Biopsy<br>* Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Recurrent Adenomas Using White Light Imaging | The number of positive diagnoses using white light optical imaging only. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology | The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using White Light Near Focus Imaging | The number of positive diagnoses using white light near focus optical imaging only. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology | The number of recurrent adenomas diagnosed positive with white light imaging near focus confirmed by standard histopathology of biopsy. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using Narrow Band Imaging | The number of positive diagnoses using narrow band optical imaging only. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology | The number of recurrent adenomas diagnosed positive with narrow band imaging confirmed by standard histopathology of biopsy. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus | The number of positive diagnoses using narrow band optical imaging near focus only. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology | The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy. | approximately 6 to 12 months post endoscopic mucosal resection | 
| Positive Recurrent Adenomas Using Biopsy | The number of positive diagnoses determined by standard histopathology assessment of biopsy. | approximately 6 to 12 months post endoscopic mucosal resection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endoscopic mucosal resection, residual polyp, near focus imaging