Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps
NCT ID: NCT01133041
Last Updated: 2011-09-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
142 participants
INTERVENTIONAL
2010-05-31
2010-10-31
Brief Summary
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Several previous studies have indicated that NBI without magnification can be useful for real-time differentiation of diminutive colonic neoplasias.
To date, however, there are no studies comparing NBI with other imaging systems (FICE or i-Scan) for differentiation of diminutive colonic polyps.
The study objectives are to compare the diagnostic efficacy of NBI with that of i-Scan in real-time prediction of diminutive colonic polyps.
In this prospective pilot study, diminutive colonic polyps detected during colonoscopy will be observed with conventional colonoscopy, thereafter will be observed with new imaging systems.
Sensitivity, specificity, and diagnostic accuracy of both NBI and i-Scan will be assessed by reference to histological results obtained by endoscopic biopsy or polypectomy.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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NBI observation
Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
i-Scan observation
Observation using i-Scan system
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Interventions
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Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Observation using i-Scan system
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age over 18
* informed consent
Exclusion Criteria
* history of hereditary colorectal cancers and polyposis syndrome
* inability to give informed consent
* use of antiplatelet agent and anticoagulants
* pregnancy
18 Years
ALL
Yes
Sponsors
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Soon Chun Hyang University
OTHER
Responsible Party
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Chang Kyun Lee
MD, PhD
Principal Investigators
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Chang Kyun Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Soon Chun Hyang University
Locations
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Soon Chung Hyang University, Cheonan hospital
Cheonan, Choongnam, South Korea
Countries
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References
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Rastogi A, Pondugula K, Bansal A, Wani S, Keighley J, Sugar J, Callahan P, Sharma P. Recognition of surface mucosal and vascular patterns of colon polyps by using narrow-band imaging: interobserver and intraobserver agreement and prediction of polyp histology. Gastrointest Endosc. 2009 Mar;69(3 Pt 2):716-22. doi: 10.1016/j.gie.2008.09.058.
Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. doi: 10.1053/j.gastro.2008.12.009. Epub 2008 Dec 10.
Hoffman A, Kagel C, Goetz M, Tresch A, Mudter J, Biesterfeld S, Galle PR, Neurath MF, Kiesslich R. Recognition and characterization of small colonic neoplasia with high-definition colonoscopy using i-Scan is as precise as chromoendoscopy. Dig Liver Dis. 2010 Jan;42(1):45-50. doi: 10.1016/j.dld.2009.04.005. Epub 2009 May 26.
Lee CK, Lee SH, Hwangbo Y. Narrow-band imaging versus I-Scan for the real-time histological prediction of diminutive colonic polyps: a prospective comparative study by using the simple unified endoscopic classification. Gastrointest Endosc. 2011 Sep;74(3):603-9. doi: 10.1016/j.gie.2011.04.049. Epub 2011 Jul 18.
Other Identifiers
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SCHCH2010L2
Identifier Type: -
Identifier Source: org_study_id