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Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Primary Purpose

Post-endoscopic Mucosal Resection of Colon Polyps

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Olympus CF190 Colonoscope High definition white light

Olympus CF190 Colonoscope White light with near focus

Olympus CF190 Colonoscope Narrow band imaging

Olympus CF190 Colonoscope Narrow band imaging with near focus

Biopsy

About this trial

This is an interventional diagnostic trial for Post-endoscopic Mucosal Resection of Colon Polyps focused on measuring Endoscopic mucosal resection, residual polyp, near focus imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Post-EMR follow up at 6-12 months

Exclusion Criteria:

Non-corrected coagulopathy
Pregnancy
Breast feeding

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Endoscopic scar assessment

Arm Description

Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.

Outcomes

Primary Outcome Measures

Positive Recurrent Adenomas Using White Light Imaging

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

Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology

The number of recurrent adenomas diagnosed positive with white light imaging confirmed by standard histopathology of biopsy.

Positive Recurrent Adenomas Using White Light Near Focus Imaging

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

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

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

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

Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology

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

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

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

The number of recurrent adenomas diagnosed positive with narrow band imaging near focus confirmed by standard histopathology of biopsy.

Positive Recurrent Adenomas Using Biopsy

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02668198

First Posted

January 23, 2016

Last Updated

September 24, 2019

Sponsor

Michael Wallace

Collaborators

Olympus America, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02668198

Brief Title

Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 2016 (Actual)

Primary Completion Date

October 2018 (Actual)

Study Completion Date

October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Michael Wallace

Collaborators

Olympus America, Inc.

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Post-endoscopic Mucosal Resection of Colon Polyps

Keywords

Endoscopic mucosal resection, residual polyp, near focus imaging

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

230 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Endoscopic scar assessment

Arm Type

Experimental

Arm Description

Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.

Intervention Type

Device

Intervention Name(s)

Olympus CF190 Colonoscope High definition white light

Intervention Description

Standard endoscopic imaging technique

Intervention Type

Device

Intervention Name(s)

Olympus CF190 Colonoscope White light with near focus

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Olympus CF190 Colonoscope Narrow band imaging

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

Olympus CF190 Colonoscope Narrow band imaging with near focus

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Biopsy

Intervention Description

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

Primary Outcome Measure Information:

Title

Positive Recurrent Adenomas Using White Light Imaging

Description

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

Time Frame