Efficacy of NICE Classification in the Histological Evaluation of Colorectal Lesions

NCT02033980 | Unknown

• 1 other identifier: rjxh[2013]125
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Colorectal Polyps

Keywords

narrow band imaging(NBI); NICE classification; colorectal lesions; predicting histology

Outcome Measures

Primary Outcomes (1)

• Accuracy of NICE classification in histological prediction by gastroenterological fellows

  Diagnostic accuracy of gastroenterological fellows using non-magnified NBI according to NICE classification in histological prediction of polyps, compared with histologic examination

  within two weeks after polypectomy

Secondary Outcomes (1)

• Diagnostic accuracy of high-definition and magnifying NBI for type 2 and type 3 lesions.

  two weeks after endoscopical or surgical resection

Study Arms (1)

colorectal lesions

OTHER

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

Device: NBI

Interventions

NBI 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.

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

colorectal lesions

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Changhai Hospital: collaborator
• Peking University People's Hospital: collaborator
• Peking Union Medical College Hospital: collaborator
• Chinese PLA General Hospital: collaborator

Study Sites (1)

Ren Ji Hospital, School of Medicine, Shanghai Jiaotong University

Shanghai, 200001, China

RECRUITING

Related Publications (1)

• Zhang QW, Zhang JJ, Yang AM, Sheng JQ, Liu YL, Li ZS, Chen HY, Feng N, Jiang QW, Jin P, Zhang LM, Fu HY, Gao YJ, Ge ZZ, Li XB. Feasibility of using narrow band imaging international colorectal endoscopic classification for diagnosing colorectal neoplasia in China: A multicenter pilot observational study. J Dig Dis. 2020 Feb;21(2):88-97. doi: 10.1111/1751-2980.12841.

  PMID: 31895484 DERIVED

Study Officials

• Zhizheng Ge, MD,Ph.D

  Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai ,China.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhizheng Ge, MD,Ph.D

CONTACT

86-21-58752345; zhizhengge@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ren Ji Hospital, School of medicine, Shanghai Jiao Tong University

Study Record Dates

• First Submitted: December 27, 2013
• First Posted: January 13, 2014
• Study Start: May 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: August 1, 2017
• Last Updated: May 10, 2016

Record last verified: 2016-05

Locations

CN (1)