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: NA
Last verified: September 2011
History: No changes posted
  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:

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.


Estimated Enrollment: 10050956
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
Genders Eligible for Study:   Both
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

No publications provided

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
Last Updated: September 8, 2011
Health Authority: China: Ethics Committee
China: Ministry of Health

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 August 19, 2014