Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

January 25, 2014 updated by: Xiaobo Li

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

418

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with early colorectal lesions

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NBI prediction for lesion histology and invasion
Time Frame: 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.
in two weeks after lesion treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
immunohistochemical outcome of microvessel count and MMP-7
Time Frame: 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
in three days after immunohistochemistry

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Xiaobo Li, Ph.D, Shanghai Ren ji Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

January 25, 2014

First Submitted That Met QC Criteria

January 25, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Estimate)

January 28, 2014

Last Update Submitted That Met QC Criteria

January 25, 2014

Last Verified

January 1, 2014

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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