The Usefulness of I-scan in Screening Colonoscopy

NCT01417611 | Completed DMC

• 1 other identifier: KUMCHSN02
• Study Type: interventional
• Target: 389
• Locations: 1 country
• Sites: 1

Brief Summary

Image-enhanced endoscopy in screening colonoscopy

1. 1.useful tool for detecting subtle epithelial lesions
2. 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.

Conditions

Colorectal Neoplasm

Keywords

screening colonoscopy

Outcome Measures

Primary Outcomes (1)

• polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis)

  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.

  up to 24 weeks

Secondary Outcomes (1)

• characterization of polyp

  up to 24 weeks

Study Arms (2)

i-scan-CE/SE

EXPERIMENTAL

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-CE/SE/TE-c

EXPERIMENTAL

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

Interventions

i-scan CE, SE, TE mode PROCEDURE

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.

Also known as: EPKi

i-scan-CE/SE; i-scan-CE/SE/TE-c

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• (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

Sponsors & Collaborators

• Konkuk University Hospital: lead

Study Sites (1)

Healthcare Center, Digestive Disease Center, Konkuk University Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Hong SN, Choe WH, Lee JH, Kim SI, Kim JH, Lee TY, Kim JH, Lee SY, Cheon YK, Sung IK, Park HS, Shim CS. Prospective, randomized, back-to-back trial evaluating the usefulness of i-SCAN in screening colonoscopy. Gastrointest Endosc. 2012 May;75(5):1011-1021.e2. doi: 10.1016/j.gie.2011.11.040. Epub 2012 Feb 28.

  PMID: 22381530 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Sung Noh Hong, M.D.

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 27, 2010
• First Posted: August 16, 2011
• Study Start: September 1, 2010
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

KR (1)