Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

Asociación Española de Gastroenterología

Status: Completed

Conditions: Colonic Polyps

Treatments: Device: NBI used by trained endoscopists

Study type: Interventional

Funder types: Other

Identifiers

NCT02328066

CEIC14/47

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,171 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion patients criteria:

• 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.

Exclusion patients criteria:

• 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.

Exclusion lesions criteria:

• 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 design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2,171 participants in 1 patient group

NBI used by trained endoscopists

Experimental group

Description:

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.

Treatment:

Device: NBI used by trained endoscopists