Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Not Applicable

Completed

Conditions: Post-endoscopic Mucosal Resection of Colon Polyps

Interventions: 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

Registration Number: NCT02668198

Lead Sponsor: Michael Wallace

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 230

Inclusion Criteria

Post-EMR follow up at 6-12 months

Exclusion Criteria

Non-corrected coagulopathy
Pregnancy
Breast feeding

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Endoscopic scar assessment	Olympus CF190 Colonoscope High definition white light	Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Endoscopic scar assessment	Olympus CF190 Colonoscope White light with near focus	Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Endoscopic scar assessment	Olympus CF190 Colonoscope Narrow band imaging	Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Endoscopic scar assessment	Biopsy	Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Endoscopic scar assessment	Olympus CF190 Colonoscope Narrow band imaging with near focus	Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.

Primary Outcome Measures

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