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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhizheng Ge, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT01431703
First received: September 8, 2011
Last updated: January 8, 2017
Last verified: January 2017
  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 Shanghai Jiao Tong University School of Medicine:

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: September 8, 2011
Results First Received: April 26, 2016
Last Updated: January 8, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Shanghai Jiao Tong University School of Medicine:
narrow band imaging
learning curve
colorectal
differential diagnosis
with colorectal lesion
NBI with magnification

ClinicalTrials.gov processed this record on March 24, 2017