The Usefulness of I-scan in Screening Colonoscopy
Primary Purpose
Colorectal Neoplasm
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
i-scan CE, SE, TE mode
Sponsored by
About this trial
This is an interventional diagnostic trial for Colorectal Neoplasm focused on measuring screening colonoscopy
Eligibility Criteria
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
Sites / Locations
- Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
i-scan-CE/SE
i-scan-CE/SE/TE-c
Arm Description
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
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
Outcomes
Primary Outcome Measures
polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis)
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.
Secondary Outcome Measures
characterization of polyp
To differentiate the adenomatous polyp from non-adenomatous polyp using colonoscopic finding
Full Information
NCT ID
NCT01417611
First Posted
July 27, 2010
Last Updated
August 15, 2011
Sponsor
Konkuk University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01417611
Brief Title
The Usefulness of I-scan in Screening Colonoscopy
Official Title
The Usefulness of I-scan in Screening Colonoscopy: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Konkuk University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasm
Keywords
screening colonoscopy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
389 (Actual)
8. Arms, Groups, and Interventions
Arm Title
i-scan-CE/SE
Arm Type
Experimental
Arm Description
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
Arm Title
i-scan-CE/SE/TE-c
Arm Type
Experimental
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
i-scan CE, SE, TE mode
Other Intervention Name(s)
EPKi
Intervention Description
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.
Primary Outcome Measure Information:
Title
polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis)
Description
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.
Time Frame
up to 24 weeks
Secondary Outcome Measure Information:
Title
characterization of polyp
Description
To differentiate the adenomatous polyp from non-adenomatous polyp using colonoscopic finding
Time Frame
up to 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung Noh Hong, M.D.
Organizational Affiliation
Konkuk University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
22381530
Citation
Hong SN, Choe WH, Lee JH, Kim SI, Kim JH, Lee TY, Kim JH, Lee SY, Cheon YK, Sung IK, Park HS, Shim CS. Prospective, randomized, back-to-back trial evaluating the usefulness of i-SCAN in screening colonoscopy. Gastrointest Endosc. 2012 May;75(5):1011-1021.e2. doi: 10.1016/j.gie.2011.11.040. Epub 2012 Feb 28.
Results Reference
derived
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The Usefulness of I-scan in Screening Colonoscopy
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