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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
  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:

U.S. FDA Resources

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 ] [ 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.


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

Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508520

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

No publications provided

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
Study First Received: January 8, 2012
Last Updated: January 11, 2012
Health Authority: China: Ethics Committee
China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on May 21, 2013