Colorectal NeoplasmNCT01417611
The Usefulness of I-scan in Screening Colonoscopy
A study testing i-scan CE, SE, TE mode in people with Colorectal Neoplasm, run by Konkuk University Hospital at 1 site in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- i-scan CE, SE, TE mode
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 389 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- (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 locations and contacts
1 site in 1 country.
South Korea1 site
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
Seoul
About this study
Official title: The Usefulness of I-scan in Screening Colonoscopy: A Randomized Controlled Trial
Image-enhanced endoscopy in screening colonoscopy
- useful tool for detecting subtle epithelial lesions
- 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.
Read the 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.
- Conditions
- Colorectal Neoplasm
- Being tested
- i-scan CE, SE, TE mode
- Keywords
- screening colonoscopy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-scan CE, SE, TE modeProcedure or surgery
Also called EPKi
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: i-scan CE, SE, TE mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 weeks
Secondary outcomes (1)
characterization of polyp
To differentiate the adenomatous polyp from non-adenomatous polyp using colonoscopic finding
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2011 (estimated)
- Study startSep 2010
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 389 participants (actual)
Sponsor and investigators
- Lead sponsor
- Konkuk University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung Noh Hong, M.D., Principal investigator, Konkuk University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01417611
- Sponsor's protocol ID
- KUMCHSN02
- Status last verified
- Aug 2011
- First submitted
- 27 Jul 2010
- Last updated
- 16 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 22381530
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of I-scan in Screening Colonoscopy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01417611
- Acronym / sponsor ID
- KUMCHSN02
- Conditions
- Colorectal Neoplasm
- Keywords
- screening colonoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 389 participants (actual)
- Lead sponsor
- Konkuk University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 16 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Image-enhanced endoscopy in screening colonoscopy
- useful tool for detecting subtle epithelial lesions
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-scan-CE/SE | Experimental | Procedure: i-scan CE, SE, TE modeStudy 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 |
| i-scan-CE/SE/TE-c | Experimental | Procedure: i-scan CE, SE, TE modeStudy 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 |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-scan CE, SE, TE modeAlso: EPKiI-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. | Procedure or surgery | i-scan-CE/SE, i-scan-CE/SE/TE-c |
Primary outcome
polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis)
Time frame: up to 24 weeks
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.
1 secondary outcome
characterization of polyp
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
- Derived from this study: PubMed 22381530Hong 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sung Noh Hong, M.D. principal investigator
Konkuk University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-scan CE, SE, TE mode in people with Colorectal Neoplasm, run by Konkuk University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
polyp/adenoma detection rate (per-polyp/adenoma analysis and per-patient analysis) (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01417611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2011.