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| Name | Class |
|---|---|
| Olympus America, Inc. | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic scar assessment | Experimental | Using endoscope with high definition white light, high definition white light with near focus, narrow band imagining, and narrow band imaging with near focus. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Olympus CF190 Colonoscope High definition white light | Device | Standard endoscopic imaging technique |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Jacksonville | Florida | 32224 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30635409 | Derived | 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. |
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 endoscopic mucosal resection (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 (NBI) with near focus: NBI with near focus to help closely examine the area of prior EMR site. Biopsy: Endoscopic colorectal mucosal resection |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 3, 2015 |
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| Olympus CF190 Colonoscope White light with near focus | Device | Near focus mode is used to closely examine the area of prior EMR site. |
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| Olympus CF190 Colonoscope Narrow band imaging | Device | Narrow band imaging is utilized to examine the area of prior EMR. |
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| Olympus CF190 Colonoscope Narrow band imaging with near focus | Device | NBI with near focus to help closely examine the area of prior EMR site. |
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| Biopsy | Procedure | Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment |
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| 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Positive Recurrent Adenomas Using White Light Imaging | The number of positive diagnoses using white light optical imaging only. | Posted | Number | adenomas with positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| 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. | Posted | Number | adenomas confirmed positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| Primary | Positive Recurrent Adenomas Using White Light Near Focus Imaging | The number of positive diagnoses using white light near focus optical imaging only. | Posted | Number | adenomas with positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| 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. | Posted | Number | adenomas confirmed positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| Primary | Positive Recurrent Adenomas Using Narrow Band Imaging | The number of positive diagnoses using narrow band optical imaging only. | Posted | Number | adenomas with positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| 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. | Posted | Number | adenomas confirmed positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| Primary | Positive Recurrent Adenomas Using Narrow Band Imaging Near Focus | The number of positive diagnoses using narrow band optical imaging near focus only. | Posted | Number | adenomas with positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| 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. | Posted | Number | adenomas confirmed positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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| Primary | Positive Recurrent Adenomas Using Biopsy | The number of positive diagnoses determined by standard histopathology assessment of biopsy. | Posted | Number | adenomas with positive diagnoses | approximately 6 to 12 months post endoscopic mucosal resection |
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Adverse events were collected during the colonoscopy procedure, an average of 30-45 minutes over approximately 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment | 0 | 230 | 0 | 230 | 0 | 230 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michael B. Wallace | Mayo Clinic | 904-953-2221 | wallace.michael@mayo.edu |
| Sep 12, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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