Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

September 26, 2011 updated by: Chang Kyun Lee, Soon Chun Hyang University

Prospective Comparison of NBI and i-Scan in Real-time Histological Prediction of Diminutive Colonic Polyps

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

142

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: NBI observation
Other: Observation using NBI system
NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
Other Names:
  • 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 Names:
  • i-Scan (Pentax, Japan)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy
Time Frame: about 1 year
Sensitivity, specificity, and diagnostic accuracy
about 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soon Chun Hyang University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (ACTUAL)

October 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

May 27, 2010

First Submitted That Met QC Criteria

May 27, 2010

First Posted (ESTIMATE)

May 28, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 27, 2011

Last Update Submitted That Met QC Criteria

September 26, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCHCH2010L2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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