a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

January 11, 2012 updated by: Xiaobo Li

Magnifying endoscopy with narrow-band imaging (ME-NBI) can emphasize surface pattern and microvascular architecture of the gastric mucosa.However,the usefulness and criteria of NBI for differential diagnosis among early gastric cancers (EGC) have not been fully established.The study is based on the hypothesis:

  1. ME-NBI is useful in distinguishing EGC from other gastric lesions
  2. ME-NBI is useful in further differential diagnosis among EGCs.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

146

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients with gastric lesions suspected of early gastric malignancy

Description

Inclusion Criteria:

  • patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.

Exclusion Criteria:

  • advanced gastric cancer or any other malignancy;
  • patients under unsuitable conditions for examination or treatment, such as acute upper gastrointestinal bleeding, noncorrectable coagulopathy, severe systemic disease, etc;
  • inability to provide informed consent;
  • inability to provide histology of resected specimens after endoscopic treatment or surgery.

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
diagnosis accuracy of ME-NBI
Time Frame: in 2 weeks after ME-NBI examination
ME-NBI diagnosis was made during real-time endoscopy procedure and reviewed in two weeks after ME-NBI examination. Sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of ME-NBI diagnosis compared with histology were measured.
in 2 weeks after ME-NBI examination

Collaborators and Investigators

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

Sponsor

Xiaobo Li

Investigators

  • Principal Investigator: Xiaobo Li, MD. 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

December 1, 2009

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

January 8, 2012

First Submitted That Met QC Criteria

January 11, 2012

First Posted (Estimate)

January 12, 2012

Study Record Updates

Last Update Posted (Estimate)

January 12, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • rjyyxhk6056

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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