Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Chang Kyun Lee, Soon Chun Hyang University

ClinicalTrials.gov Identifier:

NCT01133041

First received: May 27, 2010

Last updated: September 26, 2011

Last verified: May 2010

History of Changes

Purpose

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	Intervention	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
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

Resource links provided by NLM:

MedlinePlus related topics: Colonic Polyps Colonoscopy Nuclear Scans

U.S. FDA Resources

Further study details as provided by Soon Chun Hyang University:

Primary Outcome Measures:

Diagnostic efficacy [ Time Frame: about 1 year ] [ Designated as safety issue: No ]
Sensitivity, specificity, and diagnostic accuracy

Enrollment:	142
Study Start Date:	May 2010
Study Completion Date:	October 2010
Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

screening or surveillance colonoscopy
age over 18
informed consent

Exclusion Criteria:

history of inflammatory bowel diseases
history of hereditary colorectal cancers and polyposis syndrome
inability to give informed consent
use of antiplatelet agent and anticoagulants
pregnancy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01133041

Locations

Korea, Republic of
Soon Chung Hyang University, Cheonan hospital
Cheonan, Choongnam, Korea, Republic of, 330-721

Sponsors and Collaborators

Soon Chun Hyang University

Investigators

Principal Investigator:

Chang Kyun Lee, MD, PhD

Soon Chun Hyang University Cheonan Hospital

More Information

Publications:

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.

Rex DK. Narrow-band imaging without optical magnification for histologic analysis of colorectal polyps. Gastroenterology. 2009 Apr;136(4):1174-81. 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. Epub 2009 May 26.

Responsible Party:	Chang Kyun Lee, MD, PhD, Soon Chun Hyang University
ClinicalTrials.gov Identifier:	NCT01133041 History of Changes
Other Study ID Numbers:	SCHCH2010L2
Study First Received:	May 27, 2010
Last Updated:	September 26, 2011
Health Authority:	Korea: Institutional Review Board

Additional relevant MeSH terms:

Colonic Polyps
Hyperplasia
Polyps
Adenomatous Polyps
Intestinal Polyps
Pathological Conditions, Anatomical

Pathologic Processes
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013

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