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
1 other identifier
interventional
230
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
January 23, 2016
CompletedFirst Posted
Study publicly available on registry
January 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedResults Posted
Study results publicly available
October 17, 2019
CompletedOctober 17, 2019
September 1, 2019
2.8 years
January 23, 2016
September 24, 2019
September 24, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
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
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
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
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
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
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
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
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
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
Study Arms (1)
Endoscopic scar assessment
EXPERIMENTALUsing endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus.
Interventions
Standard endoscopic imaging technique
Near focus mode is used to closely examine the area of prior EMR site.
Narrow band imaging is utilized to examine the area of prior EMR.
NBI with near focus to help closely examine the area of prior EMR site.
Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment
Eligibility Criteria
You may qualify if:
- Post-EMR follow up at 6-12 months
You may not qualify if:
- Non-corrected coagulopathy
- Pregnancy
- Breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Michael Wallacelead
- Olympus America, Inc.collaborator
Study Sites (1)
Mayo Clinic
Jacksonville, Florida, 32224, United States
Related Publications (1)
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.
PMID: 30635409DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Michael B. Wallace
- Organization
- Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Consultant, Professor of Medicine
Study Record Dates
First Submitted
January 23, 2016
First Posted
January 29, 2016
Study Start
January 1, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
October 17, 2019
Results First Posted
October 17, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share