Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Michael Wallace

Status: Completed

Conditions: Post-endoscopic Mucosal Resection of Colon Polyps

Treatments: Device: Olympus CF190 Colonoscope Narrow band imaging with near focus; Procedure: Biopsy; Device: Olympus CF190 Colonoscope High definition white light; Device: Olympus CF190 Colonoscope Narrow band imaging; Device: Olympus CF190 Colonoscope White light with near focus

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02668198

15-007241

Details and patient eligibility

About

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

Full 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.

Enrollment: 230 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Post-EMR follow up at 6-12 months

Exclusion criteria

• Non-corrected coagulopathy
• Pregnancy
• Breast feeding

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Endoscopic scar assessment

Experimental group

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.

Treatment:

Device: Olympus CF190 Colonoscope Narrow band imaging

Procedure: Biopsy

Device: Olympus CF190 Colonoscope High definition white light

Device: Olympus CF190 Colonoscope Narrow band imaging with near focus

Device: Olympus CF190 Colonoscope White light with near focus