Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT01521091
• Lead Sponsor: Shanghai Jiao Tong University School of Medicine

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2012-01
• Study First Submitted: 2012-01-24
• Study First Submitted QC: 2012-01-27
• Last Update Submitted: 2012-01-27
• Study First Posted: 2012-01-30
• Last Update Posted: 2012-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 565

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine; 🇨🇳 Shanghai, China