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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:
Information provided by (Responsible Party):
Xiaobo Li, Shanghai Jiao Tong University
ClinicalTrials.gov Identifier:
NCT01508520
First received: January 8, 2012
Last updated: January 11, 2012
Last verified: January 2012
History of Changes

January 8, 2012
January 11, 2012
December 2009
October 2011   (final data collection date for primary outcome measure)
diagnosis accuracy of ME-NBI [ Time Frame: in 2 weeks after ME-NBI examination ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01508520 on ClinicalTrials.gov Archive Site
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a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

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.
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Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples Without DNA
Description:

Samples after biopsy or resection are to be retained.
Non-Probability Sample

patients with gastric lesions suspected of early gastric malignancy
Stomach Neoplasms
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
146
December 2011
October 2011   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01508520
rjyyxhk6056
No
Xiaobo Li, Shanghai Jiao Tong University
Xiaobo Li
Not Provided
Principal Investigator: Xiaobo Li, MD. Ph.D Shanghai Ren Ji Hospital
Shanghai Jiao Tong University School of Medicine
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP