Assessing a Endoscopic Mucosal Resection Site Using Different Endoscopic Imaging Methods

Post-endoscopic Mucosal Resection of Colon Polyps Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668198
• Other study ID #: 15-007241
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: October 2018

Study information

• Verified date: September 2019
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: October 2018
• Est. primary completion date: October 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Post-EMR follow up at 6-12 months

Exclusion Criteria:

• Non-corrected coagulopathy

• Pregnancy

• Breast feeding

Related Conditions & MeSH terms

• Colonic Polyps
• Post-endoscopic Mucosal Resection of Colon Polyps

Intervention

Device:
• 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.

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

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Michael Wallace	Olympus America, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Mayo Clinic Clinical Trials