Colon CancerNCT02724397
Linked Color Imaging/Magnifying Blue Laser Imaging vs. White Light for Adenomas and Serrated Lesions in Proximal Colon
A study testing LCI/BLI then white endoscopy and White endoscopy and then LCI/BLI in people with Colon Cancer, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. BLI was developed to compensate for the limitations of NBI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Colon Cancer
- What is being tested?
- LCI/BLI then white endoscopy and White endoscopy and then LCI/BLI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2016to 1 Oct 2017
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- --Consecutive adult patients undergoing an outpatient colonoscopy
Who cannot join
- unable to provide informed consent
- had undergone prior resection of the colon
- inflammatory bowel disease
- familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital to Academy of Military Medical Sciences
Beijing
Min Min
About this study
Official title: Linked Color Imaging (LCI) and Magnifying Blue Laser Imaging (BLI) Versus Standard White Light for the Detection of Adenomas and Serrated Lesions in the Proximal Colon
Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. BLI was developed to compensate for the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using LCI of the colon, rather than the usual white light on the colon, will improve the detection of flat adenomas and serrated polyps. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using LCI will make it easier to see them, as they can be quite difficult to see with standard white light. LCI/BLI enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and LCI/BLI, it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.
Read the detailed description
This is a randomized controlled trial comparing the use of linked color imaging (LCI) and magnifying blue laser imaging (BLI) versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). The proximal colon has large intestine and many folds which will lead missing flat lesions. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This study will test whether LCI will increase the detection of serrated lesions in a randomized controlled trial.
- Conditions
- Colon Cancer
- Being tested
- LCI/BLI then white endoscopy, White endoscopy and then LCI/BLI
- Keywords
- Colon cancer, Diagnosis, Adenoma, Serrated lesions
- Medical subject headings
- Colonic Neoplasms, Disease, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCI/BLI then white endoscopyDevice
Also called Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI)
First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas.
White endoscopy and then LCI/BLIDevice
Also called Linked Color Imaging/Magnifying Blue Laser Imaging（LCI/BLI)
First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | (White endoscopy and then LCI/BLI) The patients will be evaluated by Standard White Light and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI). Receives: Device: White endoscopy and then LCI/BLI |
| Control group | Active comparator | (LCI/BLI then white endoscopy) The patients will be evaluated by Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy. Receives: Device: LCI/BLI then white endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Proximal Serrated lesions and colorectal adenomas in proximal colon
Quantity of serrated lesions and colorectal adenomas found in the proximal colon during colonoscopy was recorded and compared.
Measured: 6 months
Secondary outcomes (1)
Improvement of histological diagnosis for serrated lesions and colorectal adenomas using LCI/BLI by comparing with that under white endoscopy
It is anticipated that the use of Linked Color Imaging (LCI) and Magnifying Blue Laser Imaging (BLI) will significantly improve the histological detection of colonic adenomas and serrated lesions when detected as opposed to White Light Endoscopy.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2016 (estimated)
- Study start1 May 2016
- Primary completion1 Oct 2017 (estimated)
- Study completion1 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Liu, M.D., Ph.D., Principal investigator, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02724397
- Sponsor's protocol ID
- 307-LCI/BLI-002
- Status last verified
- Jan 2017
- First submitted
- 18 Mar 2016
- Last updated
- 31 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Sato R, Fujiya M, Watari J, Ueno N, Moriichi K, Kashima S, Maeda S, Ando K, Kawabata H, Sugiyama R, Nomura Y, Nata T, Itabashi K, Inaba Y, Okamoto K, Mizukami Y, Saitoh Y, Kohgo Y. The diagnostic accuracy of high-resolution endoscopy, autofluorescence imaging and narrow-band imaging for differentially diagnosing colon adenoma. Endoscopy. 2011 Oct;43(10):862-8. doi: 10.1055/s-0030-1256510. Epub 2011 Jul 5.
PubMed 21732270Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
PubMed 25952085Min M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
PubMed 28286095
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linked Color Imaging (LCI) and Magnifying Blue Laser Imaging (BLI) Versus Standard White Light for the Detection of Adenomas and Serrated Lesions in the Proximal Colon
- ClinicalTrials.gov ID
- NCT02724397
- Acronym / sponsor ID
- 307-LCI/BLI-002
- Conditions
- Colon Cancer
- Keywords
- Colon cancer, Diagnosis, Adenoma, Serrated lesions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Oct 2017 (estimated)
- Study completion
- 1 Oct 2017 (estimated)
- First posted
- 31 Mar 2016 (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.
Linked color imaging (LCI) and magnifying blue laser imaging (BLI) are two new imaging systems used in endoscopy which are recently developed. BLI was developed to compensate for the limitations of NBI. BLI shows a bright image of the digestive mucosa, enabling the detailed visualization of both the microstructure and microvasculature. However, BLI still is not able to obtain sufficient brightness for distant lesions. The newly developed LCI system (FUJIFILM Co.) creates clear and bright endoscopic images by using short-wavelength narrow-band laser light combined with white laser light on the basis of BLI technology. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This is a study to determine if using LCI of the colon, rather than the usual white light on the colon, will improve the detection of flat adenomas and serrated polyps. The polyps are called serrated because of their appearance under the microscope after they have been removed. They tend to be located up high in the colon, far away from the rectum. They have been definitely shown to be a type of precancerous polyp and it is possible that using LCI will make it easier to see them, as they can be quite difficult to see with standard white light. LCI/BLI enables endoscopists to accurately describe the pit pattern of adenomas. By comparing White Light Endoscopy and LCI/BLI, it will show if there is any comparable advantage to using one or the other for lesion detection and assessment.
Detailed description
This is a randomized controlled trial comparing the use of linked color imaging (LCI) and magnifying blue laser imaging (BLI) versus standard white light for the detection of serrated lesions in the proximal colon (the colon proximal to the splenic flexure). The proximal colon has large intestine and many folds which will lead missing flat lesions. Recent studies have indicated that colonoscopy is more effective in preventing cancer in the left side of the colon than the right side of the colon. The reasons for this difference may be partly biologic, in that a special group of polyps known as serrated polyps, particularly sessile serrated adenomas, are located primarily proximal to the splenic flexure. These lesions are endoscopically subtle in that they are often flat, have the same color as the surrounding mucosa, and are hard to differentiate from normal mucosa. LCI makes red areas appear redder and white areas appear whiter. Thus, it is easier to recognize a slight difference in color of the mucosa. This study will test whether LCI will increase the detection of serrated lesions in a randomized controlled trial.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: White endoscopy and then LCI/BLI(White endoscopy and then LCI/BLI) The patients will be evaluated by Standard White Light and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI). |
| Control group | Active comparator | Device: LCI/BLI then white endoscopy(LCI/BLI then white endoscopy) The patients will be evaluated by Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- --Consecutive adult patients undergoing an outpatient colonoscopy
Key exclusion criteria (4 listed)
- unable to provide informed consent
- had undergone prior resection of the colon
- inflammatory bowel disease
- familial adenomatous polyposis, Peutz-Jeghers syndrome or other polyposis syndromes.
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 |
|---|---|---|
| LCI/BLI then white endoscopyAlso: Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI)First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas. | Device | Control group |
| White endoscopy and then LCI/BLIAlso: Linked Color Imaging/Magnifying Blue Laser Imaging（LCI/BLI)First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas. | Device | Experimental group |
Primary outcome
Number of Proximal Serrated lesions and colorectal adenomas in proximal colon
Time frame: 6 months
Quantity of serrated lesions and colorectal adenomas found in the proximal colon during colonoscopy was recorded and compared.
1 secondary outcome
Improvement of histological diagnosis for serrated lesions and colorectal adenomas using LCI/BLI by comparing with that under white endoscopy
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
- Background: PubMed 21732270Sato R, Fujiya M, Watari J, Ueno N, Moriichi K, Kashima S, Maeda S, Ando K, Kawabata H, Sugiyama R, Nomura Y, Nata T, Itabashi K, Inaba Y, Okamoto K, Mizukami Y, Saitoh Y, Kohgo Y. The diagnostic accuracy of high-resolution endoscopy, autofluorescence imaging and narrow-band imaging for differentially diagnosing colon adenoma. Endoscopy. 2011 Oct;43(10):862-8. doi: 10.1055/s-0030-1256510. Epub 2011 Jul 5.
- Results publication: PubMed 25952085Rex DK, Clodfelter R, Rahmani F, Fatima H, James-Stevenson TN, Tang JC, Kim HN, McHenry L, Kahi CJ, Rogers NA, Helper DJ, Sagi SV, Kessler WR, Wo JM, Fischer M, Kwo PY. Narrow-band imaging versus white light for the detection of proximal colon serrated lesions: a randomized, controlled trial. Gastrointest Endosc. 2016 Jan;83(1):166-71. doi: 10.1016/j.gie.2015.03.1915. Epub 2015 May 5.
- Derived from this study: PubMed 28286095Min M, Deng P, Zhang W, Sun X, Liu Y, Nong B. Comparison of linked color imaging and white-light colonoscopy for detection of colorectal polyps: a multicenter, randomized, crossover trial. Gastrointest Endosc. 2017 Oct;86(4):724-730. doi: 10.1016/j.gie.2017.02.035. Epub 2017 Mar 9.
- Individual participant dataSharing planned: Undecided
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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.
Yan Liu, M.D., Ph.D. principal investigator
Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LCI/BLI then white endoscopy and White endoscopy and then LCI/BLI in people with Colon Cancer, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
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 4 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: status not confirmed, as of the sponsor's last update on 31 Jan 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Min Min, M.D., Ph.D. (+86-010-66947473, minmin823@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Proximal Serrated lesions and colorectal adenomas in proximal colon (time frame: 6 months). 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 NCT02724397, which also lists 3 linked publications.
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 31 Jan 2017.