Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

Colorectal Neoplasms Clinical Trial

Official title:

Observation of Microvessels and Invasion in Early Colorectal Lesions by Narrow Band Imaging:Combination With Microvessel Count and MMP-7 Expression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02047188
• Other study ID #: 12YZ036
• Status: Completed
• Phase: N/A
• First received: January 25, 2014
• Last updated: January 25, 2014
• Start date: January 2010
• Est. completion date: December 2013

Study information

• Verified date: January 2014
• 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

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 418
• Est. completion date: December 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colorectal Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Xiaobo Li

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NBI prediction for lesion histology and invasion	We will receive the histologic findings in two weeks after lesion treatment.Then we can compare NBI prediction with the final histologic type.	in two weeks after lesion treatment	Yes
Secondary	immunohistochemical outcome of microvessel count and MMP-7	We will receive the immunohistochemical outcome in three days after immunohistochemistry.Then we can compare NBI prediction with immunohistochemical outcome	in three days after immunohistochemistry	Yes