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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01508520
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : January 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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.

Condition or disease
Stomach Neoplasms

Study Design

Study Type : Observational
Actual Enrollment : 146 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
Study Start Date : December 2009
Primary Completion Date : October 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples Without DNA
Samples after biopsy or resection are to be retained.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with gastric lesions suspected of early gastric malignancy
Criteria

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01508520


Sponsors and Collaborators
Xiaobo Li
Investigators
Principal Investigator: Xiaobo Li, MD. Ph.D Shanghai Ren Ji Hospital
More Information

Responsible Party: Xiaobo Li, Shanghai Institute of Digestive Disease,Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier: NCT01508520     History of Changes
Other Study ID Numbers: rjyyxhk6056
First Posted: January 12, 2012    Key Record Dates
Last Update Posted: January 12, 2012
Last Verified: January 2012

Keywords provided by Xiaobo Li, Shanghai Jiao Tong University:
early gastric cancer
stomach neoplasms
magnifying endoscopy
narrow band imaging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases