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Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China

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What is being tested

NBI

Device
Who is being recruted

From 18 to 90 Years
+6 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: May 2016
See protocol details

Summary

Principal SponsorShanghai Jiao Tong University School of Medicine
Study ContactZhizheng Ge, MD,Ph.D
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2016

Actual date on which the first participant was enrolled.

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.

Official TitleEfficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions ----- a Multicenter Study in China
NCT02033980
Principal SponsorShanghai Jiao Tong University School of Medicine
Study ContactZhizheng Ge, MD,Ph.D
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

400 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

2 inclusion criteria required to participate
Patients with colorectal lesions during colonoscopy examination

Informed consent available

4 exclusion criteria prevent from participating
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, ChinaOpen Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University in Google Maps
SuspendedOne Study Center