Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

NCT ID: NCT02668198

Last Updated: 2019-10-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2018-10-31

Brief Summary

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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

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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.

Conditions

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Post-endoscopic Mucosal Resection of Colon Polyps

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Olympus CF190 Colonoscope High definition white light

Intervention Type DEVICE

Standard endoscopic imaging technique

Olympus CF190 Colonoscope White light with near focus

Intervention Type DEVICE

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

Olympus CF190 Colonoscope Narrow band imaging

Intervention Type DEVICE

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

Olympus CF190 Colonoscope Narrow band imaging with near focus

Intervention Type DEVICE

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

Biopsy

Intervention Type PROCEDURE

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

Interventions

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Olympus CF190 Colonoscope High definition white light

Standard endoscopic imaging technique

Intervention Type DEVICE

Olympus CF190 Colonoscope White light with near focus

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

Intervention Type DEVICE

Olympus CF190 Colonoscope Narrow band imaging

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

Intervention Type DEVICE

Olympus CF190 Colonoscope Narrow band imaging with near focus

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

Intervention Type DEVICE

Biopsy

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

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Post-EMR follow up at 6-12 months

Exclusion Criteria

* Non-corrected coagulopathy
* Pregnancy
* Breast feeding
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Olympus America, Inc.

INDUSTRY

Sponsor Role collaborator

Michael Wallace

OTHER

Sponsor Role lead

Responsible Party

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Michael Wallace

Consultant, Professor of Medicine

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Mayo Clinic

Jacksonville, Florida, United States

Site Status

Countries

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United States

References

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Kandel P, Brand EC, Pelt J, Ball CT, Chen WC, Bouras EP, Gomez V, Raimondo M, Woodward TA, Wallace MB; EMR SCAR Group. Endoscopic scar assessment after colorectal endoscopic mucosal resection scars: when is biopsy necessary (EMR Scar Assessment Project for Endoscope (ESCAPE) trial). Gut. 2019 Sep;68(9):1633-1641. doi: 10.1136/gutjnl-2018-316574. Epub 2019 Jan 11.

Reference Type DERIVED
PMID: 30635409 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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Other Identifiers

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15-007241

Identifier Type: -

Identifier Source: org_study_id

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