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Completed

NCT Number: NCT02047188

Observation of Microvessels and Invasion in Early Colorectal Lesions by NBI

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Xiaobo Li

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2014
Registry last updated
Jan 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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