Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02668198

Enrollment

230

Registered

2016-01-29

Start date

2016-01-31

Completion date

2018-10-31

Last updated

2019-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-endoscopic Mucosal Resection of Colon Polyps

Keywords

Endoscopic mucosal resection, residual polyp, near focus imaging

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.

Interventions

DEVICEOlympus CF190 Colonoscope High definition white light

Standard endoscopic imaging technique

DEVICEOlympus CF190 Colonoscope White light with near focus

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

DEVICEOlympus CF190 Colonoscope Narrow band imaging

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

DEVICEOlympus CF190 Colonoscope Narrow band imaging with near focus

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

PROCEDUREBiopsy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Post-EMR follow up at 6-12 months

Exclusion criteria

* Non-corrected coagulopathy * Pregnancy * Breast feeding

Design outcomes

Primary

Measure	Time frame	Description
Positive Recurrent Adenomas Using White Light Imaging	approximately 6 to 12 months post endoscopic mucosal resection	The number of positive diagnoses using white light optical imaging only.
Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology	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.
Positive Recurrent Adenomas Using White Light Near Focus Imaging	approximately 6 to 12 months post endoscopic mucosal resection	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	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.
Positive Recurrent Adenomas Using Narrow Band Imaging	approximately 6 to 12 months post endoscopic mucosal resection	The number of positive diagnoses using narrow band optical imaging only.
Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology	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.
Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus	approximately 6 to 12 months post endoscopic mucosal resection	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	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.
Positive Recurrent Adenomas Using Biopsy	approximately 6 to 12 months post endoscopic mucosal resection	The number of positive diagnoses determined by standard histopathology assessment of biopsy.

Countries

United States

Participant flow

Participants by arm

Arm	Count
Endoscopic Scar Assessment Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Endoscopic colorectal mucosal resection	230
Total	230

Arm

Count

Endoscopic Scar Assessment

Using endoscope with high definition white light, high definition white light with near focus, narrow band imaging, and narrow band imaging with near focus. Olympus CF190 Colonoscope High definition white light: Standard endoscopic imaging technique Olympus CF190 Colonoscope White light with near focus: Near focus mode is used to closely examine the area of prior EMR site. Olympus CF190 Colonoscope Narrow band imaging: Narrow band imaging is utilized to examine the area of prior EMR. Olympus CF190 Colonoscope Narrow band imaging with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Endoscopic colorectal mucosal resection

230

Total

230

Baseline characteristics

Characteristic	Endoscopic Scar Assessment	—
Age, Continuous	65.5 years	—
Race and Ethnicity Not Collected	—	— Participants
Region of Enrollment United States	230 participants	—
Sex: Female, Male Female	113 Participants	—
Sex: Female, Male Male	117 Participants	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 230
other Total, other adverse events	0 / 230
serious Total, serious adverse events	0 / 230