Hyperplastic PolypsFICE;NICENCT02263144
Resect and Discard Extension to FICE of NIcE Classification
An observational study of Hyperplastic Polyps and Adenomatous Polyps, run by Istituto Clinico Humanitas at 7 sites in 5 countries.
Trial summary
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hyperplastic Polyps, Adenomatous Polyps
- What is being tested?
- virtual chromo-endoscopy using FICE Fujifilm Technology
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 7 sitesin 5 countries
- Study dates
- May 2014to Dec 2014
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Consecutive adult patients who were referred for elective outpatient colonoscopy
Who may be able to join
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
- The patient is at satisfactory risk to undergo abdominal surgery;
- The patient must understand and provide written consent for the procedure.
Who cannot join
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis.
- Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
- Personal history of coagulation disorders or use of anticoagulants
- Patients who are currently enrolled in another clinical investigation in which the intervention might compromise the safety of the patient's participation in this study.
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites, 2 recruiting
- Recruiting
Department of Medicine I, University of Erlangen-Nürnberg Medical School
Erlangen
Helmut Neumann, MD, helmut.neumann@uk-erlangen.de
Helmut Neumann, MD
- Recruiting
Dept of Gastroenterology and interventional Endoscopy, Krankenhaus Barmherzige Brüder
Regensburg
Oliver Pech, MD, oliver.pech@t-online.de
Oliver Pech, MD
Italy2 sites, 2 recruiting
- Recruiting
Digestive Endoscopy Unit, Nuovo Regina Margherita Hospital
Rome
Cesare Hassan, MD, cesareh@hotmail.com
Cesare Hassan, MD
- Recruiting
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, 20089
Alessandro Repici, MD, +39282247493, alessandro.repici@humanitas.it
Alessandro Repici, MD
Belgium1 site, 1 recruiting
- Recruiting
Dept of Gastroenterology and Endoscopy, University Hospital
Leuven
Raf Bisschops, MD, raf.bisschops@med.kuleuven.be
Raf Bisschops, MD
France1 site, 1 recruiting
- Recruiting
Dept of Gastroenterology, Edouard Herriot Hospital, Hospices Civils of Lyon
Lyon
Thierry Ponchon, MD, thierry.ponchon@chu-lyon.fr
Thierry Ponchon, MD
United Kingdom1 site, 1 recruiting
- Recruiting
Solent Centre for Digestive Diseases , Royal Alexandra Hospital
Portsmouth
Pradeep Bhandari, MD, pradeep.bhandari@porthosp.nhs.uk
Pradeep Bhandari, MD
About this study
Official title: Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.
Read the detailed description
- In order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. A short video-clip (around 15-20 seconds) of each polyp both at white-light and FICE-light will be recorded and stored in an anonymized database.
- Once the video-library is completed, each of 7 experts will independently review all the cases. For each case, any observer will assess each of the three NICE criteria (colour/vascularization/surface), the degree of confidence (low/high), and classify the lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE technology with high-definition and without magnification, when adopting NICE classification, to differentiate between hyperplastic and adenomatous lesions, and the inter-observer agreement in such differentiation. Secondary end-points are to assess at multivariate measure the role of any individual criteria of NICE classification in the discrimination between the two histotypes, and possible adaptations of NICE classification in order to be applied with FICE.
- Conditions
- Hyperplastic Polyps, Adenomatous Polyps
- Being tested
- virtual chromo-endoscopy using FICE Fujifilm Technology
- Medical subject headings
- Adenomatous Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual chromo-endoscopy using FICE Fujifilm TechnologyProcedure or surgery
For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
| Study group | Role | What they receive |
|---|---|---|
| histologically-verified <10mm polyps | histologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology Receives: Procedure: virtual chromo-endoscopy using FICE Fujifilm Technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.
7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.
Measured: up to 6 months
Inter-observer agreement among the 7 experts
The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (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 Hyperplastic PolypsStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Royal Alexandra Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Nuovo Regina Margherita Hospital, University of Erlangen-Nürnberg Medical School, University Hospital Regensburg, Hôpital Edouard Herriot
- Responsible party
- Principal investigator, Michele Tedeschi, Istituto Clinico Humanitas
- Investigators
- Alessandro Repici, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02263144
- Sponsor's protocol ID
- REDEFINE
- Acronym
- FICE;NICE
- Status last verified
- Oct 2014
- First submitted
- 25 Sep 2014
- Last updated
- 13 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
PubMed 22609383
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resect and Discard Extension to Fuji Intelligent Color Enhancement (FICE) of Narrow Band Imaging International Colorectal Endoscopic (NicE) Classification
- ClinicalTrials.gov ID
- NCT02263144
- Acronym / sponsor ID
- FICE;NICE / REDEFINE
- Conditions
- Hyperplastic Polyps, Adenomatous Polyps
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Royal Alexandra Hospital, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), Nuovo Regina Margherita Hospital, University of Erlangen-Nürnberg Medical School, University Hospital Regensburg, Hôpital Edouard Herriot
- Study start
- May 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Oct 2014 (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.
The purpose of this prospective, non-interventional study is to validate the Narrow Band Imaging International Colorectal Endoscopic (NICE) classification for differentiating subcentimetric hyperplastic and adenomatous polyps by using Fuji Intelligent Color Enhancement (FICE) technology with high-definition without optical magnification.
Detailed description
- In order to create a video-library of endoscopic cases, patients undergoing screening or diagnostic colonoscopy will be considered for inclusion. Patients with at least one histologically verified <10 mm polyp will be included. A short video-clip (around 15-20 seconds) of each polyp both at white-light and FICE-light will be recorded and stored in an anonymized database.
- Once the video-library is completed, each of 7 experts will independently review all the cases. For each case, any observer will assess each of the three NICE criteria (colour/vascularization/surface), the degree of confidence (low/high), and classify the lesion as neoplastic or non-neoplastic. The primary outcomes are the accuracy of FICE technology with high-definition and without magnification, when adopting NICE classification, to differentiate between hyperplastic and adenomatous lesions, and the inter-observer agreement in such differentiation. Secondary end-points are to assess at multivariate measure the role of any individual criteria of NICE classification in the discrimination between the two histotypes, and possible adaptations of NICE classification in order to be applied with FICE.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| histologically-verified <10mm polyps | – | Procedure: virtual chromo-endoscopy using FICE Fujifilm Technologyhistologically-verified <10mm polyps, analyzed by virtual chromo-endoscopy using FICE Fujifilm Technology |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Consecutive adult patients who were referred for elective outpatient colonoscopy
Key inclusion criteria (3 listed)
- The patient is undergoing colonoscopy for screening, for surveillance in follow-up of previous polypectomy or for diagnostic work-up;
- The patient is at satisfactory risk to undergo abdominal surgery;
- The patient must understand and provide written consent for the procedure.
Key exclusion criteria (7 listed)
- Patients with inflammatory bowel disease;
- Patients with a personal history of polyposis syndrome;
- Patients with diverticulitis or toxic megacolon;
- Patients with a history of radiation therapy to abdomen or pelvis.
- Patients with a history of severe cardiovascular, pulmonary, liver or renal disease;
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 |
|---|---|---|
| virtual chromo-endoscopy using FICE Fujifilm TechnologyFor each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology | Procedure or surgery | histologically-verified <10mm polyps |
Primary outcome
accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts.
Time frame: up to 6 months
7 experts will review videos from a video-library of subcentimetric polyps removed and histologically verified and will assess each of the three NICE criteria (colour/vascularization/surface), and classify the lesion as neoplastic or non-neoplastic with low or high confidence.
Inter-observer agreement among the 7 experts
Time frame: up to 6 months
The inter-observer agreement, among the 7 experts, on the final diagnosis (neoplastic or non-neoplastic) and on each individual NICE criterion for each polyp will be determined by using K statistics .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2014.
- Background: PubMed 22609383Hewett DG, Kaltenbach T, Sano Y, Tanaka S, Saunders BP, Ponchon T, Soetikno R, Rex DK. Validation of a simple classification system for endoscopic diagnosis of small colorectal polyps using narrow-band imaging. Gastroenterology. 2012 Sep;143(3):599-607.e1. doi: 10.1053/j.gastro.2012.05.006. Epub 2012 May 15.
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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.
Alessandro Repici, MD principal investigator
Istituto Clinico Humanitas
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperplastic Polyps and Adenomatous Polyps, run by Istituto Clinico Humanitas at 7 sites in 5 countries.
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 3 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 13 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, Italy, Belgium, France, United Kingdom. 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 Alessandro Repici, MD (+39282247493, alessandro.repici@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of the NICE criteria using FICE technology for differentiating between the non-neoplastic and neoplastic histotypes in diagnoses with high-confidence on a video-library of 110 polyps reviewed by 7 experts. (time frame: up to 6 months). The study lists 2 primary outcomes in all. 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 NCT02263144, 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 13 Oct 2014.