Colonic PolypsNICENCT02328066
Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion
A study testing NBI used by trained endoscopists in people with Colonic Polyps, run by Asociación Española de Gastroenterología at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Polyps
- What is being tested?
- NBI used by trained endoscopists
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,171 participants
- Where
- 1 siteSpain
- Study dates
- Jul 2014to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients> 18 years
- Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.
- Achievable histology by endoscopic or surgical resection.
- Writing informed consent given.
Who cannot join
- Age <18 years.
- Refusal to give informed consent.
- Contraindication for endoscopic or surgical resection.
- Urgent colonoscopy indication (eg severe rectorrhagia.).
- Patients with inflammatory bowel disease.
- Suspected metastatic neoplasia by previous imaging tests.
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- Polyp previously biopsied or resected.
- Poor preparation that does not allow a proper assessment of the lesion.
- NBI not performed.
- Unavailable or indefinite histology (endoscopic or surgical resection).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
The purpose of this study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.
Read the detailed description
In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program.
In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.
Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
- Conditions
- Colonic Polyps
- Being tested
- NBI used by trained endoscopists
- Keywords
- NBI, NICE classification, deep submucosal invasion, Colonic Polyps [C23.300.825.411.235], Colonoscopy [E01.370.372.250.250.200]
- Medical subject headings
- Colonic Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NBI used by trained endoscopistsDevice
Also called Narrow Band Imaging, NICE classification
Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.
| Study group | Role | What they receive |
|---|---|---|
| NBI used by trained endoscopists | Experimental | Assessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists. Receives: Device: NBI used by trained endoscopists |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of NICE classification to predict deep submucosal invasion
Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies.
Gold standard (histology):
- positive means adenocarcinoma with deep submucosal invasion (>1 mm)
- negative means non adenocarcinoma or superficial adenocarcinoma (<1 mm)
Evaluated test (NICE classification):
- Positive means NICE type 3.
- Negative means NICE type 1 and 2.
Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)
Measured: 1 year
Secondary outcomes (4)
Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test
Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the pre-learning test.
Measured: 0
Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test
Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion in the post-learning test (pre-clinical test)
Measured: 0
Preplanned potential factors that could influence diagnostic accuracy of NICE classification
Related to the lesion: Size (mm); location: rectum/sigmoid/left colon/splenic flexure/transverse colon/hepatic flexure/right colon and cecum; Morphology according to the Paris classification (see categories in the reference article); Level of confidence: high/low; Successful complete submucosal injection: yes/no/not done; Chicken skin's sign: yes/no; Edges retraction: yes/no; Depressed areas: yes/no; Folds convergence: yes/no; Induration: yes/no; Obvious ulceration: yes/no; Polyp on polyp: yes/no; Technical resection: 8 categories according to the current practice.
Related to the equipment: Colonoscope: 11 colonoscope models; Videoprocessor: Exera II, Exera III; Monitor: high definition, non-high definition
Related to the endoscopist: Hospital type: Secondary or tertiary; Endoscopy experience (number of years); Previous experience in chromoendoscopy: yes/no; Previous experience in NBI: yes/no; Number of lesions included in the study; Review histology and images monthly: yes/no
Measured: 1 year
Histological predictors of lymph node metastases of pT1
- Histological type: adenocarcinoma, mucinous adenocarcinoma, cell carcinoma with signet ring, undifferentiated carcinoma, other.
- Histologic Grade: Low Grade (well-moderately differentiated) or High-grade (poorly dif, undifferentiated, mucinous, signet ring).
- Horizontal size of adenocarcinoma (mm)
- Level of submucosal adenocarcinoma (mm)
- Angiolymphatic invasion of small vessels: Present or absent
- Perineural invasion: Present or Absent.
- Tumor budding: Absent, Low grade (5-9 groups of 5 cells per field with 20x objective), High Grade (≥10 groups of 5 cells per field with 20x objective)
- Polyp type that originated carcinoma: Tubular adenoma, Villous adenoma, Adenoma/sessile serrated polyp, Traditional serrated adenoma, Other
- Resection margin: Negative or Positive
- Size of negative margin (mm).
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2014 (estimated)
- Study startJul 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic PolypsStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2,171 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asociación Española de Gastroenterología
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pablo Vega, Principal investigator, Complexo Hospitalario de OurenseMaria Luisa de Castro, Principal investigator, Complexo Hospitalario Universitario de Vigo-CHUVIEva Martínez-Bauer, Principal investigator, Corporacion Parc TauliAngel Fernández, Principal investigator, Hospital Clínico de ZaragozaGema de la Poza, Principal investigator, Hospital de FuenlabradaJorge López, Principal investigator, Hospital de MóstolesOscar Nogales, Principal investigator, Gregorio Marañón HospitalBeatriz Peñas, Principal investigator, Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02328066
- Sponsor's protocol ID
- CEIC14/47
- Acronym
- NICE
- Status last verified
- Jun 2018
- First submitted
- 8 Dec 2014
- Last updated
- 27 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.
PubMed 23910062Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
PubMed 30296432
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion in Colon Lesions. Prospective Multicenter Study in Routine Clinical Practice
- ClinicalTrials.gov ID
- NCT02328066
- Acronym / sponsor ID
- NICE / CEIC14/47
- Conditions
- Colonic Polyps
- Keywords
- NBI, NICE classification, deep submucosal invasion, Colonic Polyps [C23.300.825.411.235], Colonoscopy [E01.370.372.250.250.200]
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,171 participants (actual)
- Lead sponsor
- Asociación Española de GastroenterologíaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 31 Dec 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 study is to evaluate the diagnostic accuracy of NICE classification to predict deep submucosal invasion of colonic polyps > 1 cm, considering histology as the gold standard, in a group of endoscopists who previously performed a training program.
Detailed description
In the first phase of the study, a learning program of NICE classification based on examples will be performed. Forty images will be evaluated before and after the learning program.
In the second phase of the study, all consecutive patients who underwent to a colonoscopy will be included if a lesion greater than 1 cm is found and the endoscopy is performed with a high definition colonoscope with Narrow Band Imaging (NBI). Patients, lesions and endoscopy equipment characteristics will be recorded.
Subsequently, histological diagnosis of the lesion will also be recorded. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology). In case of adenocarcinomas, histological predictors of lymph node metastases, with predefined assessment criteria, will also be recorded.
Finally, histological preparations of adenocarcinomas will be sent to the reference center and two experienced pathologists will examine them again.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NBI used by trained endoscopists | Experimental | Device: NBI used by trained endoscopistsAssessment with NICE classification and NBI technology of colonic lesions (Paris classification type 0) greater than 1 cm found in a routine colonoscopy. This assessment was performed by previously trained endoscopists. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients> 18 years
- Lesion Type 0 of Paris classification, greater than 1 cm, found in a colonoscopy performed by any medical indication with a high definition endoscope with Narrow Band Imaging.
- Achievable histology by endoscopic or surgical resection.
- Writing informed consent given.
Key exclusion criteria (10 listed)
- Age <18 years.
- Refusal to give informed consent.
- Contraindication for endoscopic or surgical resection.
- Urgent colonoscopy indication (eg severe rectorrhagia.).
- Patients with inflammatory bowel 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 |
|---|---|---|
| NBI used by trained endoscopistsAlso: Narrow Band Imaging, NICE classificationExamination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on. | Device | NBI used by trained endoscopists |
Primary outcome
Diagnostic accuracy of NICE classification to predict deep submucosal invasion
Time frame: 1 year
Sensibility, specificity, negative predictive value and positive predictive value of NICE classification to predict deep submucosal invasion during routine colonoscopies. Gold standard (histology): * positive means adenocarcinoma with deep submucosal invasion (>1 mm) * negative means non adenocarcinoma or superficial adenocarcinoma (<1 mm) Evaluated test (NICE classification): * Positive means NICE type 3. * Negative means NICE type 1 and 2. Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology)
4 secondary outcomes
Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the pre-learning test
Time frame: 0
Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test
Time frame: 0
Preplanned potential factors that could influence diagnostic accuracy of NICE classification
Time frame: 1 year
Histological predictors of lymph node metastases of pT1
Time frame: 1 year
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 27 Jun 2018.
- Background: PubMed 23910062Hayashi N, Tanaka S, Hewett DG, Kaltenbach TR, Sano Y, Ponchon T, Saunders BP, Rex DK, Soetikno RM. Endoscopic prediction of deep submucosal invasive carcinoma: validation of the narrow-band imaging international colorectal endoscopic (NICE) classification. Gastrointest Endosc. 2013 Oct;78(4):625-32. doi: 10.1016/j.gie.2013.04.185. Epub 2013 Jul 30.
- Derived from this study: PubMed 30296432Puig I, Lopez-Ceron M, Arnau A, Rosinol O, Cuatrecasas M, Herreros-de-Tejada A, Ferrandez A, Serra-Burriel M, Nogales O, Vida F, de Castro L, Lopez-Vicente J, Vega P, Alvarez-Gonzalez MA, Gonzalez-Santiago J, Hernandez-Conde M, Diez-Redondo P, Rivero-Sanchez L, Gimeno-Garcia AZ, Burgos A, Garcia-Alonso FJ, Bustamante-Balen M, Martinez-Bauer E, Penas B, Pellise M; EndoCAR group, Spanish Gastroenterological Association and the Spanish Digestive Endoscopy Society. Accuracy of the Narrow-Band Imaging International Colorectal Endoscopic Classification System in Identification of Deep Invasion in Colorectal Polyps. Gastroenterology. 2019 Jan;156(1):75-87. doi: 10.1053/j.gastro.2018.10.004. Epub 2018 Oct 6.
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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.
Pablo Vega principal investigator
Complexo Hospitalario de Ourense
Maria Luisa de Castro principal investigator
Complexo Hospitalario Universitario de Vigo-CHUVI
Eva Martínez-Bauer principal investigator
Corporacion Parc Tauli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NBI used by trained endoscopists in people with Colonic Polyps, run by Asociación Española de Gastroenterología at 1 site in Spain.
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 4 inclusion and 10 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 27 Jun 2018. 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 Spain. 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?
Diagnostic accuracy of NICE classification to predict deep submucosal invasion (time frame: 1 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 NCT02328066, which also lists 2 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 27 Jun 2018; AzTrials last refreshed its copy on 4 Nov 2026.