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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
Sponsor:
Collaborator:
Olympus America, Inc.
Information provided by (Responsible Party):
Michael Wallace, Mayo Clinic

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

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

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 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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 230 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Kudo's Pit Pattern Classification for colorectal neoplasm [ Time Frame: 6-12 months after initial EMR of initial colon lesions ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Post-EMR follow up at 6-12 months

Exclusion Criteria:

  • Non-corrected coagulopathy
  • Pregnancy
  • Breast feeding

Information from the National Library of Medicine

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


Locations
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United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Michael Wallace
Olympus America, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael Wallace, Consultant, Professor of Medicine, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02668198     History of Changes
Other Study ID Numbers: 15-007241
First Posted: January 29, 2016    Key Record Dates
Last Update Posted: January 7, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Michael Wallace, Mayo Clinic:
Endoscopic mucosal resection, residual polyp, near focus imaging
Additional relevant MeSH terms:
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Colonic Polyps
Polyps
Pathological Conditions, Anatomical
Intestinal Polyps