Adenoma Colon PolypNCT03279783
LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
A study testing LCI (Linked color imaging) in people with Adenoma Colon Polyp, run by Valduce Hospital at 1 site in Italy.
Trial summary
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Adenoma Colon Polyp
- What is being tested?
- LCI (Linked color imaging)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 1 siteItaly
- Study dates
- 1 Jul 2017to 30 Dec 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all outpatients referred for colonoscopy
Who cannot join
- inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
- previous colonic resection
- inflammatory bowel disease
- ereditary polyposic syndromes
- patients on antithrombotics precluding polyp recetion
- absence of informed consent
- inpatients or patients undergoing urgent colonscopy
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gastroenterology Unit, Valduce Hospital
Como, 22100
Franco Radaelli, MD, 0039031324145, francoradaelli01@gmail.com
About this study
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention.
Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon.
Read more
The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy.
Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).
- Conditions
- Adenoma Colon Polyp
- Being tested
- LCI (Linked color imaging)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LCI (Linked color imaging)Device
Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)
| Study group | Role | What they receive |
|---|---|---|
| WLI (White light Imaging) | No intervention | Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light. |
| LCI (Linked Color Imaging) | Active comparator | Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging). Receives: Device: LCI (Linked color imaging) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Right colon adenoma miss rate
Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection
Measured: One year
Secondary outcomes (2)
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate
Number of advanced adenomas identified during the second right coloninspection/ overall number of advanced adenomas identified during the first and the second right colon inspection
Measured: One year
Right colon sessile serrated lesions miss rate
Number of sessile serrated lesions identified during the second right coloninspection/ overall number of sessile serrated lesions identified during the first and the second right colon inspection
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start1 Jul 2017
- Primary completion1 Dec 2017 (estimated)
- Study completion30 Dec 2017 (estimated)
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 Adenoma Colon PolypStudies 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
- Sequential
- Model description
- Participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back-to-back fashion, with standard white light (WL) and with LCI (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 752 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Valduce Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Franco Radaelli, Valduce Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279783
- Sponsor's protocol ID
- 341/2017
- Status last verified
- Sep 2017
- First submitted
- 24 Aug 2017
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.
PubMed 29539651
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LCI (Linked Color Imaging) for Adenoma Detection in the Right Colon
- ClinicalTrials.gov ID
- NCT03279783
- Acronym / sponsor ID
- 341/2017
- Conditions
- Adenoma Colon Polyp
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 752 participants (estimated)
- Lead sponsor
- Valduce HospitalUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2017 (estimated)
- Study completion
- 30 Dec 2017 (estimated)
- First posted
- 12 Sep 2017 (actual)
- 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.
Although colonoscopy with polypectomy can prevent up to 80% of colorectal cancers, a significant adenoma miss rate still exists, particularly in the right colon. Optimizing the detection of adenomas and sessile serrated lesions in the right colon is crucial to increase the effectiveness of colonoscopy in colorectal cancer prevention.
Last generation Fuji videocolonscopes incorporates the Linked Color Imaging (LCI), a recently developed technology that differentiates the red colour spectrum more effectively than White Light imaging thanks to its optimal pre-process composition of light spectrum and advanced signal processing. The increased colour contrast results in more accurate delineation of abnormal inflammatory or neoplastic findings of colonic mucosa. Preliminary data suggest that LCI may be improve the detection of neoplastic lesion of colon.
The investigators performe a tandem prospective study to compare the right colon adenoma miss rates of LCI colonoscopy with those of conventional white light colonoscopy.
Therefore participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back to back fashion, with standard white light (WL) and with LCI. Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first. The endoscopist are masked to group allocation until immediately before the cecum is reached. Examinations are performed with Fuji videocolonscopes series 700 (EC-760R, EC-760ZP).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants scheduled for colonoscopy for the assessment of symptoms or for colorectal cancer screening/surveillance receive the examination of the right colon twice, in a back-to-back fashion, with standard white light (WL) and with LCI (Linked Color Imaging). Patients are randomly assigned (1:1), via computer-generated randomisation with block size of 20, to which procedure is done first.
| Arm | Type | Receives |
|---|---|---|
| WLI (White light Imaging) | No intervention | –Colonoscope withdrawal was performed in the right colon evaluating the mucosa using standard white light. |
| LCI (Linked Color Imaging) | Active comparator | Device: LCI (Linked color imaging)Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked Color Imaging). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all outpatients referred for colonoscopy
Key exclusion criteria (7 listed)
- inadequatete bowel preparation (Boston Bowel Preparation Scale (BBPS) < 2 in one colonic segment)
- previous colonic resection
- inflammatory bowel disease
- ereditary polyposic syndromes
- patients on antithrombotics precluding polyp recetion
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 (Linked color imaging)Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging) | Device | LCI (Linked Color Imaging) |
Primary outcome
Right colon adenoma miss rate
Time frame: One year
Number of adenomas identified during the second right coloninspection/ overall number of adenomas identified during the first and the second right colon inspection
2 secondary outcomes
Right colon advanced adenomas (size>1 cm and/or high grade displasia and/or villous component) miss rate
Time frame: One year
Right colon sessile serrated lesions miss rate
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
- Derived from this study: PubMed 29539651Paggi S, Mogavero G, Amato A, Rondonotti E, Andrealli A, Imperiali G, Lenoci N, Mandelli G, Terreni N, Conforti FS, Conte D, Spinzi G, Radaelli F. Linked color imaging reduces the miss rate of neoplastic lesions in the right colon: a randomized tandem colonoscopy study. Endoscopy. 2018 Apr;50(4):396-402. doi: 10.1055/a-0580-7405. Epub 2018 Mar 14.
- Individual participant dataSharing planned: No
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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.
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 (Linked color imaging) in people with Adenoma Colon Polyp, run by Valduce Hospital at 1 site in Italy.
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 7 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 12 Sep 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 Italy. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right colon adenoma miss rate (time frame: One year). 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 NCT03279783, 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 12 Sep 2017.