NCT01133041

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
142

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started May 2010

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

September 27, 2011

Status Verified

May 1, 2010

Enrollment Period

5 months

First QC Date

May 27, 2010

Last Update Submit

September 26, 2011

Conditions

Diminutive Colon PolypAdenomatous PolypHyperplastic PolypColonoscopy

Outcome Measures

Primary Outcomes (1)

  • Diagnostic efficacy

    Sensitivity, specificity, and diagnostic accuracy

    about 1 year

Study Arms (2)

NBI observation

EXPERIMENTAL
Other: Observation using NBI system

i-Scan observation

EXPERIMENTAL
Other: Observation using i-Scan system

Interventions

Observation using NBI systemOTHER

NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.

Also known as: NBI, narrow band imaging (Olympus, Japan)
NBI observation
Observation using i-Scan systemOTHER

I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.

Also known as: i-Scan (Pentax, Japan)
i-Scan observation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • screening or surveillance colonoscopy
  • age over 18
  • informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soon Chung Hyang University, Cheonan hospital

Cheonan, Choongnam, 330-721, South Korea

Location

Related Publications (4)

  • 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.

    PMID: 19251016BACKGROUND

  • 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.

    PMID: 19187781BACKGROUND

  • 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.

    PMID: 19473893BACKGROUND

  • 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.

    PMID: 21762907DERIVED

MeSH Terms

Conditions

Adenomatous Polyps

Interventions

Narrow Band Imaging

Condition Hierarchy (Ancestors)

AdenomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

Optical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Chang Kyun Lee, MD, PhD

    Soon Chun Hyang University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

May 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

September 27, 2011

Record last verified: 2010-05

Locations

KR(1)