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OpenTrials
Completed

NCT Number: NCT02668198

Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

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

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Key information

Conditions

Post-endoscopic Mucosal Resection of Colon Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic

Jacksonville, Florida, 32224, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Post-EMR follow up at 6-12 months

Exclusion criteria

  • Non-corrected coagulopathy
  • Pregnancy
  • Breast feeding

Treatment and study plan

Olympus CF190 Colonoscope High definition white light

Device

Standard endoscopic imaging technique

Olympus CF190 Colonoscope White light with near focus

Device

Near focus mode is used to closely examine the area of prior EMR site.

Olympus CF190 Colonoscope Narrow band imaging

Device

Narrow band imaging is utilized to examine the area of prior EMR.

Olympus CF190 Colonoscope Narrow band imaging with near focus

Device

NBI with near focus to help closely examine the area of prior EMR site.

Biopsy

Procedure

Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

Primary outcomes

  1. Positive Recurrent Adenomas Using White Light Imaging

    Time frame: approximately 6 to 12 months post endoscopic mucosal resection

    The number of positive diagnoses using white light optical imaging only.

  2. Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology

    Time frame: 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.

  3. Positive Recurrent Adenomas Using White Light Near Focus Imaging

    Time frame: approximately 6 to 12 months post endoscopic mucosal resection

    The number of positive diagnoses using white light near focus optical imaging only.

  4. Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology

    Time frame: 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.

  5. Positive Recurrent Adenomas Using Narrow Band Imaging

    Time frame: approximately 6 to 12 months post endoscopic mucosal resection

    The number of positive diagnoses using narrow band optical imaging only.

  6. Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology

    Time frame: 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.

  7. Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus

    Time frame: approximately 6 to 12 months post endoscopic mucosal resection

    The number of positive diagnoses using narrow band optical imaging near focus only.

  8. Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology

    Time frame: 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.

  9. Positive Recurrent Adenomas Using Biopsy

    Time frame: approximately 6 to 12 months post endoscopic mucosal resection

    The number of positive diagnoses determined by standard histopathology assessment of biopsy.

Sponsors and collaborators

Lead sponsor

Michael Wallace

Other

Collaborators

  • Olympus America, Inc.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 29, 2016
Registry last updated
Oct 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.