Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Recently, a new category classification (NICE classification) using non-magnified NBI has been proposed. We design this multicenter study to evaluate the reliability and validity of the NICE classification in diagnosing colorectal polyps by Chinese endoscopists during both image and real-time process.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Diagnostic Accuracy of NICE Classification to Predict Deep Submucosal Invasion

NCT02328066

Colonic Polyps

COMPLETED NA

Prevalence and Characteristics of Nonpolypoid Colorectal Neoplasms - A Chinese Cohort Study

NCT01533311

Nonpolypoid Colorectal Neoplasms(NP-CRN)

COMPLETED

Comparison of Diagnostic Accuracies of Various Endoscopic Examination Techniques

NCT03109938

Colorectal Cancer

UNKNOWN

Computer-based Classification of Colorectal Polyps Using Narrow-band Imaging

NCT01262248

Colorectal Polyps

COMPLETED

Comparative Study of Postprocessing Imaging Systems for Diminutive Colonic Polyps

NCT01133041

Diminutive Colon Polyp Adenomatous Polyp Hyperplastic Polyp +1 more

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Many reports have demonstrated the efficacy of narrow band imaging (NBI) with magnification in predicting the histology and invasion depth of colorectal polyps. In China, however, the magnifying endoscope is not used in some medical centers. Even in centers equipped with this technique, the magnifying colonoscope is not sufficiently used in daily practice. Recently, a simple category classification (NICE classification) using non-magnified NBI has been proposed, which classifies colorectal tumors into types 1-3 based on different characteristics of color, surface pattern, and microvessels. Type-1 is considered an index for hyperplastic lesions, type-2 is an index for adenoma or mucosal/SM scanty invasive carcinoma and type-3 is an index for deep SM invasive carcinoma. The new classification has soon arouse attention and been validated in some centers on the efficacy of differentiating adenomatous and hyperplastic polyps. However, most studies enrolled diminutive polyps less than 5mm and the efficacy of non-magnified NBI in differentiating type-2 and type-3 lesions has not been reported. To promote this simple classification, we design this multicenter study to evaluate the predictive validity and performance characteristics of the non-magnified NBI in diagnosing polyps during both image and real-time process.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Polyps

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

colorectal lesions

All lesions will be observed with NBI and removed endoscopically or surgically for histological diagnosis.

Group Type OTHER

NBI

Intervention Type DEVICE

All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NBI

All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Evis Lucera system (CV-260, Olympus Inc, Japan) high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan) magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patients with colorectal lesions during colonoscopy examination
* Informed consent available

Exclusion Criteria

* Suspect of advanced colorectal cancer
* History of colorectal surgery, familial adenomatous polyposis or inflammatory bowel disease
* Poor bowel preparation
* Patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No