The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

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ClinicalTrials.gov Identifier: NCT01431703

Recruitment Status : Completed

First Posted : September 9, 2011

Results First Posted : March 1, 2017

Last Update Posted : March 1, 2017

Sponsor:

Information provided by (Responsible Party):

Zhizheng Ge, Shanghai Jiao Tong University School of Medicine

Study Description

Brief Summary:

It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

Condition or disease
Colorectal Lesion

Detailed Description:

It is very useful to use narrow-band imaging and Sano CP analysis in the differential diagnosis of colorectal lesions. The endoscopists who had never used NBI or no knowledge of NBI can have effective and stable diagnostic accuracy after using NBI with magnification to diagnose 15 target and non-target lesions respectively.

Study Design

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Study Type :	Observational
Actual Enrollment :	326 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
Study Start Date :	May 2010
Actual Primary Completion Date :	April 2011
Actual Study Completion Date :	April 2011

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Accuracy, Sensitivity, and Specificity for Differentiating Neoplastic and Non-neoplastic Lesions [ Time Frame: For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained. ]

Biospecimen Retention: Samples Without DNA

if the lesion is neoplastic or sm deeper cancer, we just take biopsy.If the lesion is adenomatous or sm1-2 cancer,we do polypectomy, EMR or ESD to get the specimen.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	16 Years to 85 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

academic hospital endoscopist of digestive department

Criteria

Inclusion Criteria:

Ages 16 to 85
Any patient undergoing NBI with magnification colonoscopy exam and found with colorectal lesions

Exclusion Criteria:

Unwilling to consent
Had surgery of colorectal tumors
Using NSAIDS
Diagnosed or suspected IBD
Familial adenomatous polyposis(FAP) or hereditary non-polyposis colorectal(HNPCC) or other hereditary disease

Contacts and Locations

No Contacts or Locations Provided

More Information

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Responsible Party:	Zhizheng Ge, Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier:	NCT01431703
Other Study ID Numbers:	rjyyxhk0923
First Posted:	September 9, 2011 Key Record Dates
Results First Posted:	March 1, 2017
Last Update Posted:	March 1, 2017
Last Verified:	January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Zhizheng Ge, Shanghai Jiao Tong University School of Medicine:


narrow band imaging learning curve colorectal	differential diagnosis with colorectal lesion NBI with magnification

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