Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

September 24, 2019 updated by: Michael Wallace

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post-EMR follow up at 6-12 months

Exclusion Criteria:

  • Non-corrected coagulopathy
  • Pregnancy
  • Breast feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Endoscopic scar assessment
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
Standard endoscopic imaging technique
Device: Olympus CF190 Colonoscope White light with near focus
Near focus mode is used to closely examine the area of prior EMR site.
Device: Olympus CF190 Colonoscope Narrow band imaging
Narrow band imaging is utilized to examine the area of prior EMR.
Device: Olympus CF190 Colonoscope Narrow band imaging with near focus
NBI with near focus to help closely examine the area of prior EMR site.
Procedure: Biopsy
Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection
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.
approximately 6 to 12 months post endoscopic mucosal resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael Wallace

Collaborators

Olympus America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2016

Primary Completion (Actual)

October 1, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

January 23, 2016

First Submitted That Met QC Criteria

January 26, 2016

First Posted (Estimate)

January 29, 2016

Study Record Updates

Last Update Posted (Actual)

October 17, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-007241

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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