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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NBI used by trained endoscopists | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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):
Evaluated test (NICE classification):
Evaluated test (NICE classification) was blinded to the pathologist who performed the gold standard test (histology) | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 0 |
| Diagnostic accuracy of NICE classification to predict deep submucosal invasion in the post-learning test |
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Inclusion patients criteria:
Exclusion patients criteria:
Exclusion lesions criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Vega | Complexo Hospitalario de Ourense | Principal Investigator |
| Maria Luisa de Castro | Complexo Hospitalario Universitario de Vigo-CHUVI | Principal Investigator |
| Eva Martínez-Bauer | Corporacion Parc Tauli | Principal Investigator |
| Angel Fernández | Hospital Clínico de Zaragoza | Principal Investigator |
| Gema de la Poza | Hospital de Fuenlabrada | Principal Investigator |
| Jorge López | Hospital de Móstoles | Principal Investigator |
| Oscar Nogales | Gregorio Marañón Hospital | Principal Investigator |
| Beatriz Peñas | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Pilar Díez | Hospital Río Ortega | Principal Investigator |
| Marta Hernández |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ignasi Puig | Manresa | Barcelona | 08241 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23910062 | Background | 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. | |
| 30296432 |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062048 | Narrow Band Imaging |
| ID | Term |
|---|---|
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
|
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) |
| 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 | 1 year |
| Histological predictors of lymph node metastases of pT1 |
| 1 year |
| Hospital Universitario Puerta de Hierro |
| Principal Investigator |
| Antonio Zebenzuy | Hospital Universitario de Canarias | Principal Investigator |
| Aurora Burgos | Hospital Universitario La Paz | Principal Investigator |
| Jorge Mendoza | Fundación de Investigación Biomédica - Hospital Universitario de La Princesa | Principal Investigator |
| Marco Antonio Álvarez | Hospital del Mar | Principal Investigator |
| Puig 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. |
| D008919 |
| Investigative Techniques |