Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01133041|
Recruitment Status : Completed
First Posted : May 28, 2010
Last Update Posted : September 27, 2011
Several novel imaging technologies are currently used for detection and differentiation of colonic polyps during colonoscopy, such as NBI (Olympus), FICE (Fujinon), and i-Scan (Pentax).
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.
|Condition or disease||Intervention/treatment||Phase|
|Diminutive Colon Polyp Adenomatous Polyp Hyperplastic Polyp Colonoscopy||Other: Observation using NBI system Other: Observation using i-Scan system||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||142 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||October 2010|
|Actual Study Completion Date :||October 2010|
|Experimental: NBI observation||
Other: Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Other Name: NBI, narrow band imaging (Olympus, Japan)
|Experimental: i-Scan observation||
Other: Observation using i-Scan system
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Other Name: i-Scan (Pentax, Japan)
- Diagnostic efficacy [ Time Frame: about 1 year ]Sensitivity, specificity, and diagnostic accuracy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01133041
|Korea, Republic of|
|Soon Chung Hyang University, Cheonan hospital|
|Cheonan, Choongnam, Korea, Republic of, 330-721|
|Principal Investigator:||Chang Kyun Lee, MD, PhD||Soon Chun Hyang University|