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NCT01521091 Clinical Trial

Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Colorectal Neoplasms Clinical Trial

Official title:
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions Using Magnifying Colonoscopy With Narrow Band Imaging, Indigo Carmine, and Acetic Acid Staining

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01521091
Other study ID # rjxhnk01
Secondary ID
Status Completed
Phase N/A
First received January 24, 2012
Last updated January 27, 2012
Start date January 2009
Est. completion date December 2010

Study information
Verified date January 2012
Source Shanghai Jiao Tong University School of Medicine
Contact n/a
Is FDA regulated No
Health authority China: Ethics CommitteeChina: Ministry of Health
Study type Observational

Clinical Trial Summary

Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the first choice.

Description:

To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.

Recruitment information / eligibility
Status Completed
Enrollment 565
Est. completion date December 2010
Est. primary completion date December 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Consecutive patients with more than one lesion ? 6mm .

Exclusion Criteria:

- Patients with chronic inflammatory bowel disease, advanced cancer, insufficient bowel preparation, familial adenomatous polyposis (FAP)

- Lesions ? 5mm and submucosal tumor (SMT).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
China Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

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