Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods
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|ClinicalTrials.gov Identifier: NCT02668198|
Recruitment Status : Completed
First Posted : January 29, 2016
Last Update Posted : January 7, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post-endoscopic Mucosal Resection of Colon Polyps||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||Not Applicable|
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 colonscopes 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 colonscopy can be lengthened.
Hypothesis of the study: Using standard white light with and without near focus does not provide better sensitivity and negative predictive value compare to narrow band imaging with and without near focus when assessing previous endoscopic mucosal resection (EMR) site for residual neoplasia
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnostic Accuracy of Using Colonoscope With Near Focus Capability in Detecting Residual Colorectal Neoplastic Tissue After EMR: a Prospective Study|
|Actual Study Start Date :||January 2016|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||October 2018|
Active Comparator: High definition white light
All procedures will be performed by using a high-definition colonoscope (Olympus CFH190) with the near focus mode capability.
This is the standard endoscopic imaging technique.
Device: Olympus CF190 Colonoscope High definition white light
Standard endoscopic imaging technique
Active Comparator: White light with near focus
For the 190 systems, the polyp was examined in standard focus and near focus modes, which provided in-focus images up to 2 mm from the optical lens, thus allowing true optical, in-focus zoom.
Near focus is used to help examine for any residual polyps.
Device: Olympus CF190 Colonoscope White light with near focus
Near focus mode is used to closely examine the area of prior EMR site.
Active Comparator: Narrow band imaging
Narrow band imaging
Device: Olympus CF190 Colonoscope Narrow band imaging
Narrow band imaging is utilized to examine the area of prior EMR.
Active Comparator: Narrow band imaging with near focus
Narrow band imaging with near focus.
Device: Olympus CF190 Colonoscope Narrow band imaging with near focus
NBI with near focus to help closely examine for any residual polyp at the prior site of resection.
- Paris Endoscopic Classification [ Time Frame: 6-12 months after initial EMR of initial colon lesions ]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
- Kudo's Pit Pattern Classification for colorectal neoplasm [ Time Frame: 6-12 months after initial EMR of initial colon lesions ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02668198
|United States, Florida|
|Jacksonville, Florida, United States, 32224|