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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01508520
First Posted: January 12, 2012
Last Update Posted: January 12, 2012
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.
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University
  Purpose

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
Stomach Neoplasms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Xiaobo Li, Shanghai Jiao Tong University:

Primary Outcome Measures:
  • 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.

Enrollment: 146
Study Start Date: December 2009
Study Completion Date: December 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
  Eligibility

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 Submitted: January 8, 2012
First Posted: January 12, 2012
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