- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01431703
The Learning Curve of NBI With Magnification in the Diagnosis of Colorectal Lesions
January 8, 2017 updated by: Zhizheng Ge
It exists a learning curve in using NBI with magnification to differentiating colorectal lesions.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
326
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 85 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
academic hospital endoscopist of digestive department
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
For this training, patients were consecutively enrolled until a total of 45 target and non-target lesions were obtained.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
April 1, 2011
Study Registration Dates
First Submitted
September 8, 2011
First Submitted That Met QC Criteria
September 8, 2011
First Posted (Estimate)
September 9, 2011
Study Record Updates
Last Update Posted (Actual)
March 1, 2017
Last Update Submitted That Met QC Criteria
January 8, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rjyyxhk0923
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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