The Usefulness of I-scan in Screening Colonoscopy

Konkuk University Hospital

Status: Completed

Conditions: Colorectal Neoplasm

Treatments: Procedure: i-scan CE, SE, TE mode

Study type: Interventional

Funder types: Other

Identifiers

NCT01417611

KUMCHSN02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 389 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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389 participants in 2 patient groups

i-scan-CE/SE

Experimental group

Description:

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

Treatment:

Procedure: i-scan CE, SE, TE mode

i-scan-CE/SE/TE-c

Experimental group

Description:

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

Treatment:

Procedure: i-scan CE, SE, TE mode