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Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

Primary Purpose

Diminutive Colon Polyp, Adenomatous Polyp, Hyperplastic Polyp

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Observation using NBI system
Observation using i-Scan system
Sponsored by
Soon Chun Hyang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diminutive Colon Polyp

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Soon Chung Hyang University, Cheonan hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

NBI observation

i-Scan observation

Arm Description

Outcomes

Primary Outcome Measures

Diagnostic efficacy
Sensitivity, specificity, and diagnostic accuracy

Secondary Outcome Measures

Full Information

First Posted
May 27, 2010
Last Updated
September 26, 2011
Sponsor
Soon Chun Hyang University
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1. Study Identification

Unique Protocol Identification Number
NCT01133041
Brief Title
Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps
Official Title
Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soon Chun Hyang University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diminutive Colon Polyp, Adenomatous Polyp, Hyperplastic Polyp, Colonoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
142 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NBI observation
Arm Type
Experimental
Arm Title
i-Scan observation
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Observation using NBI system
Other Intervention Name(s)
NBI, narrow band imaging (Olympus, Japan)
Intervention Description
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Intervention Type
Other
Intervention Name(s)
Observation using i-Scan system
Other Intervention Name(s)
i-Scan (Pentax, Japan)
Intervention Description
I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Primary Outcome Measure Information:
Title
Diagnostic efficacy
Description
Sensitivity, specificity, and diagnostic accuracy
Time Frame
about 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chang Kyun Lee, MD, PhD
Organizational Affiliation
Soon Chun Hyang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soon Chung Hyang University, Cheonan hospital
City
Cheonan
State/Province
Choongnam
ZIP/Postal Code
330-721
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
19251016
Citation
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.
Results Reference
background
PubMed Identifier
19187781
Citation
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.
Results Reference
background
PubMed Identifier
19473893
Citation
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.
Results Reference
background
PubMed Identifier
21762907
Citation
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.
Results Reference
derived

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Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

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