Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

Completed

• Conditions: Colorectal Neoplasms

• Registration Number: NCT02047188
• Lead Sponsor: Xiaobo Li

Brief Summary

Combined with magnifying endoscopy,narrow-band imaging (NBI) contrasts microvascular architecture on lesion surface.The histology of early colorectal lesions could be predicted under NBI view.However,its capability for estimating invasion depth remains to be verified.The study is based on the hypothesis:NBI can predict histology and invasion depth,combined with the verification of microvessel count and MMP-7 expression.

Detailed Description

The microvessel count (MVC) is a classical method of assessing histologic grade.To verify whether NBI could predict histology through microvascular architecture,we measured lesion microvessels by immunohistochemistry.On the other hand,we applied immunohistochemistry of matrix metalloproteinase-7 (MMP-7) to validate the capability of NBI for estimating invasion depth.MMP-7 is directly involved in the processes of growth, invasion, and metastasis of colorectal cancer.Our target was to clarify the diagnostic accuracy of magnifying NBI in early colorectal lesions,combined with the verification of microvessel count and MMP-7 expression.

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2013-05
• Study Completion: 2013-12
• Status Verified: 2014-01
• Study First Submitted: 2014-01-25
• Study First Submitted QC: 2014-01-25
• Last Update Submitted: 2014-01-25
• Study First Posted: 2014-01-28
• Last Update Posted: 2014-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 418

Inclusion Criteria

• patients of early colorectal lesions with capillary pattern(CP) type II&III,initially detected by white-light view and then examined by NBI with magnifying endoscopy.

Exclusion Criteria

• lesions with CP type I;
• CP type III lesions with an obvious appearance of advanced cancer;
• lesions that had underwent biopsy;
• patients with inflammatory bowel disease(IBD) or familial adenomatous polyposis(FAP)
• patients with previous colorectal surgery;
• having conditions associated with cardiac,hepatic,renal,and coagulopathy diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
NBI prediction for lesion histology and invasion	in two weeks after lesion treatment	We will receive the histologic findings in two weeks after lesion treatment.Then we can compare NBI prediction with the final histologic type.

Secondary Outcome Measures

Name	Time	Method
immunohistochemical outcome of microvessel count and MMP-7	in three days after immunohistochemistry	We will receive the immunohistochemical outcome in three days after immunohistochemistry.Then we can compare NBI prediction with immunohistochemical outcome