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NCT Number: NCT01133041

Comparative Study of Postprocessing Imaging Systems for 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.

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Key information

Conditions

Diminutive Colon Polyp Adenoma Adenomatous Polyp Adenomatous Polyps Colonoscopy Hyperplastic Polyp Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Soon Chung Hyang University, Cheonan hospital

Cheonan, Choongnam, 330-721, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation using NBI system

Other

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

Other names: NBI, narrow band imaging (Olympus, Japan)

Observation using i-Scan system

Other

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

Other names: i-Scan (Pentax, Japan)

Primary outcomes

  1. Diagnostic efficacy

    Time frame: about 1 year

    Sensitivity, specificity, and diagnostic accuracy

Sponsors and collaborators

Lead sponsor

Soon Chun Hyang University

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 28, 2010
Registry last updated
Sep 27, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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