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This study is a randomized controlled trial to determine whether i-scan can improve the detection of conventional adenomas and sessile serrated adenomas/polyps.
This is a randomized controlled trial comparing the use of i-scan (digital surface and contrast enhancement of the mucosa) versus standard high-definition white light for the detection of conventional adenomas and sessile serrated adenomas/polyps. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as sessile serrated adenomas/polyps (SSA) are located primarily proximal to the splenic flexure. Sessile serrated adenomas/polyps share molecular features with a group of cancers that occur primarily in the proximal colon. These molecular features include CpG island methylator phenotype (CIMP) and microsatellite instability. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. Recent studies have shown that image enhanced endoscopy can highlight the appearance of these lesions. This study will test whether i-scan increases the detection of conventional adenomas and sessile serrated adenomas/polyps in a randomized controlled trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| i-scan | Active Comparator | Inspection with i-scan surface enhancement |
|
| Standard high-definition white light | Active Comparator | Inspection with standard high-definition white light (usual care) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| i-scan | Device | examination will be performed with i-scan digital enhancement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Conventional Adenoma Detected | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeffrey K Lee, MD | Primary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Francisco Medical Center | San Francisco | California | 94115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29935326 | Derived | Kidambi TD, Terdiman JP, El-Nachef N, Singh A, Kattah MG, Lee JK. Effect of I-scan Electronic Chromoendoscopy on Detection of Adenomas During Colonoscopy. Clin Gastroenterol Hepatol. 2019 Mar;17(4):701-708.e1. doi: 10.1016/j.cgh.2018.06.024. Epub 2018 Jun 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention (I-scan) | i-scan 1 (surface enhancement with contrast enhancement) |
| FG001 | Control (HDWL) | HDWL (High definition white light) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | I-scan | Inspection with i-scan surface enhancement i-scan: examination will be performed with i-scan digital enhancement |
| BG001 | Standard High-definition White Light | Inspection with standard high-definition white light (usual care) standard high-definition white light: examination will be performed with high-definition white light |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Conventional Adenoma and Sessile Serrated Adenoma/Polyp Detected | Posted | Count of Participants | Participants | 12 months |
|
|
12 months
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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 | Intervention (I-scan) | i-scan 1 (surface enhancement with contrast enhancement) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trilokesh Kidambi | University of California San Francisco | 909-973-0629 | tkgastromd@gmail.com |
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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 | Jan 5, 2017 | Mar 25, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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| standard high-definition white light | Device | examination will be performed with high-definition white light |
|
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| body mass index | Mean | Standard Deviation | kg/m^2 |
|
|
| Secondary | Number of Participants With Conventional Adenoma Detected | Posted | Count of Participants | Participants | 12 months |
|
|
|
| 0 |
| 369 |
| 0 |
| 369 |
| 0 |
| 369 |
| EG001 | Control (HDWL) | HDWL (High definition white light) | 0 | 371 | 0 | 371 | 0 | 371 |
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| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |