- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01417611
The Usefulness of I-scan in Screening Colonoscopy
The Usefulness of I-scan in Screening Colonoscopy: A Randomized Controlled Trial
Image-enhanced endoscopy in screening colonoscopy
- useful tool for detecting subtle epithelial lesions
- useful tool for predicting real-time histology of epithelial lesions. Among image-enhancing techniques, i-SCAN is new developed and the practical usefulness of i-scan for screening colonoscopy has not been investigated yet.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
New technologies have been developed to enhance the visualization of colorectal mucosa to unmask even minute mucosal lesions and identify neoplastic lesion from non-neoplastic lesions. In particular, there appears to be strong evidence that pan-colonic chromoendoscopy enhances the detection of colorectal neoplasm in the colon and rectum. However, this technique is time-consuming because of both the dye spraying and suction of collected dye in the dependent portion, and therefore it is unsuitable for routine application. To overcome this inconvenience, optical-digital method involves conversion of the optical characteristics of the light used for illumination or imaging with a light source differing in optical characteristics from ordinary white light (WL), such as narrow band imaging (NBI), Fujinon imaging color enhancement (FICE), auto-fluorescence imaging (AFI) and infra-red imaging (IRI).
I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques.19 I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE). The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time. Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation. Furthermore, while NBI) images are much darker than conventional white light (WL) images, i-scan images are as bright as conventional WL images, therefore, i-scan is able to observe much larger areas in a distant view compared with NBI. Consequently, i-scan might be more useful for performing screening endoscopy).
However, the actual usefulness of I-scan in enhancing the detection of colonic neoplastic lesions is not known yet in screening colonoscopy. Therefore, we tried to evaluate the hypothesis that, in subjects undergoing colonoscopy screening, the routine application of i-scan during withdrawal could improve adenoma detection as compared with standard WL examination.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Seoul, Korea, Republic of
- Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- a consecutive series of asymptomatic average-risk subjects aged 40-75 years who underwent first screening colonoscopy at the Healthcare Center of Konkuk University Medical Center in Seoul, Korea
Exclusion Criteria:
- (i) the colonoscopy did not reach the cecum, (ii) the bowel preparation was poor or inadequate (iii) patients taking anticoagulants that precluded removal of polyps during colonoscopy, (iv) patients had a history of bowel resection, or (v) patients who refused to participate or were unable to provide informed consent to the study (vi) patients with melanosis coli
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: i-scan-CE/SE
Study Group using i-scan SE and CE mode: i-scan-CE/SE group was explored whole colon from the cecum to the rectum with i-scan-CE 2+ and SE 2+ mode.
They had a chance to switch from i-scan to WL to perform polyp removal using cold biopsy or polypectomy
|
I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques.
I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE).
The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time.
Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation.
Other Names:
|
Experimental: i-scan-CE/SE/TE-c
Study Group using i-scan SE & CE mode as well as TE-c mode: i-scan-CE/SE/TE-c group was explored whole colon from the cecum to the rectum with i-scan CE2+, SE2+, TE-c mode.
They had a chance to switch from i-scan to WL to perform polyp removal using cold biopsy or polypectomy
|
I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques.
I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE).
The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time.
Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis)
Time Frame: up to 24 weeks
|
To compare the polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis) among conventional WL, i-scan-CE/SE or i-scan-CE/SE/TE-c groups.
|
up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
characterization of polyp
Time Frame: up to 24 weeks
|
To differentiate the adenomatous polyp from non-adenomatous polyp using colonoscopic finding
|
up to 24 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sung Noh Hong, M.D., Konkuk University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KUMCHSN02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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