Clinical trial NCT02668198: 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
Overall status: COMPLETED
Phase: NA
Conditions: Post-endoscopic Mucosal Resection of Colon Polyps
Keywords: Endoscopic mucosal resection, residual polyp, near focus imaging
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Olympus America, Inc.
First posted: 2016-01-29
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: Inclusion Criteria:

* Post-EMR follow up at 6-12 months

Exclusion Criteria:

* Non-corrected coagulopathy
* Pregnancy
* Breast feeding

Primary outcomes:
measure: Positive Recurrent Adenomas Using White Light Imaging
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using White Light Imaging Confirmed by Histology
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using White Light Near Focus Imaging
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using White Light Near Focus Imaging Confirmed by Histology
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using Narrow Band Imaging
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using Narrow Band Imaging Confirmed by Histology
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus Confirmed by Histology
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
measure: Positive Recurrent Adenomas Using Biopsy
timeFrame: approximately 6 to 12 months post endoscopic mucosal resection
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
Study officials:
References:
citation: 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.