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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01431703
First Posted: September 9, 2011
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University
  Purpose
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.

Condition
Colorectal Lesion

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions

Further study details as provided by Zhizheng Ge, Shanghai Jiao Tong University:

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.

Enrollment: 326
Study Start Date: May 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 85 Years   (Child, Adult, Senior)
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

Responsible Party: Zhizheng Ge, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01431703     History of Changes
Other Study ID Numbers: rjyyxhk0923
First Submitted: September 8, 2011
First Posted: September 9, 2011
Results First Submitted: April 26, 2016
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:
narrow band imaging
learning curve
colorectal
differential diagnosis
with colorectal lesion
NBI with magnification