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The Usefulness of I-scan in Screening Colonoscopy

This study has been completed.
Sponsor:
Information provided by:
Konkuk University Hospital
ClinicalTrials.gov Identifier:
NCT01417611
First received: July 27, 2010
Last updated: August 15, 2011
Last verified: August 2011
History of Changes
  Purpose

Image-enhanced endoscopy in screening colonoscopy

  1. useful tool for detecting subtle epithelial lesions
  2. useful tool for predicting real-time histology of epithelial lesions. Among image-enhancing techniques, i-SCAN is new developed and the practical usefulness of i-scan for screening colonoscopy has not been investigated yet.

Condition Intervention
Colorectal Neoplasm
 Procedure: i-scan CE, SE, TE mode

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: The Usefulness of I-scan in Screening Colonoscopy: A Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Konkuk University Hospital:

Primary Outcome Measures:
  • polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis) [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    To compare the polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis) among conventional WL, i-scan-CE/SE or i-scan-CE/SE/TE-c groups.


Secondary Outcome Measures:
  • characterization of polyp [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
    To differentiate the adenomatous polyp from non-adenomatous polyp using colonoscopic finding


Enrollment: 389
Study Start Date: September 2010
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: i-scan-CE/SE
Study Group using i-scan SE and CE mode: i-scan-CE/SE group was explored whole colon from the cecum to the rectum with i-scan-CE 2+ and SE 2+ mode. They had a chance to switch from i-scan to WL to perform polyp removal using cold biopsy or polypectomy
 Procedure: i-scan CE, SE, TE mode
I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques. I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE). The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time. Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation.
Other Name: EPKi
Experimental: i-scan-CE/SE/TE-c
Study Group using i-scan SE & CE mode as well as TE-c mode: i-scan-CE/SE/TE-c group was explored whole colon from the cecum to the rectum with i-scan CE2+, SE2+, TE-c mode. They had a chance to switch from i-scan to WL to perform polyp removal using cold biopsy or polypectomy
 Procedure: i-scan CE, SE, TE mode
I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques. I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE). The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time. Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation.
Other Name: EPKi

Detailed Description:

New technologies have been developed to enhance the visualization of colorectal mucosa to unmask even minute mucosal lesions and identify neoplastic lesion from non-neoplastic lesions. In particular, there appears to be strong evidence that pan-colonic chromoendoscopy enhances the detection of colorectal neoplasm in the colon and rectum. However, this technique is time-consuming because of both the dye spraying and suction of collected dye in the dependent portion, and therefore it is unsuitable for routine application. To overcome this inconvenience, optical-digital method involves conversion of the optical characteristics of the light used for illumination or imaging with a light source differing in optical characteristics from ordinary white light (WL), such as narrow band imaging (NBI), Fujinon imaging color enhancement (FICE), auto-fluorescence imaging (AFI) and infra-red imaging (IRI).

I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques.19 I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE). The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time. Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation. Furthermore, while NBI) images are much darker than conventional white light (WL) images, i-scan images are as bright as conventional WL images, therefore, i-scan is able to observe much larger areas in a distant view compared with NBI. Consequently, i-scan might be more useful for performing screening endoscopy).

However, the actual usefulness of I-scan in enhancing the detection of colonic neoplastic lesions is not known yet in screening colonoscopy. Therefore, we tried to evaluate the hypothesis that, in subjects undergoing colonoscopy screening, the routine application of i-scan during withdrawal could improve adenoma detection as compared with standard WL examination.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a consecutive series of asymptomatic average-risk subjects aged 40-75 years who underwent first screening colonoscopy at the Healthcare Center of Konkuk University Medical Center in Seoul, Korea

Exclusion Criteria:

  • (i) the colonoscopy did not reach the cecum, (ii) the bowel preparation was poor or inadequate (iii) patients taking anticoagulants that precluded removal of polyps during colonoscopy, (iv) patients had a history of bowel resection, or (v) patients who refused to participate or were unable to provide informed consent to the study (vi) patients with melanosis coli
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01417611

Locations
Korea, Republic of
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Konkuk University Hospital
Investigators
Principal Investigator: Sung Noh Hong, M.D. Konkuk University Medical Center
  More Information

No publications provided by Konkuk University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Sung Noh Hong, M.D., Digestive Disease Center, Healthcare Center, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT01417611     History of Changes
Other Study ID Numbers: KUMCHSN02
Study First Received: July 27, 2010
Last Updated: August 15, 2011
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Konkuk University Hospital:
screening colonoscopy

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on May 16, 2013