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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.
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University Identifier:
First received: January 8, 2012
Last updated: January 11, 2012
Last verified: January 2012

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.

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 Shanghai Jiao Tong University School of Medicine:

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)

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

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
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Please refer to this study by its identifier: NCT01508520

Sponsors and Collaborators
Xiaobo Li
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 Identifier: NCT01508520     History of Changes
Other Study ID Numbers: rjyyxhk6056
Study First Received: January 8, 2012
Last Updated: January 11, 2012

Keywords provided by Shanghai Jiao Tong University School of Medicine:
early gastric cancer
stomach neoplasms
magnifying endoscopy
narrow band imaging

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases processed this record on May 24, 2017