Trial Information
a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only, Time Perspective: Prospective
Outcome Measure:
diagnosis accuracy of ME-NBI
Outcome Description:
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.
Outcome Time Frame:
in 2 weeks after ME-NBI examination
Safety Issue:
No
Principal Investigator
Xiaobo Li, MD. Ph.D
Investigator Role:
Principal Investigator
Investigator Affiliation:
Shanghai Ren Ji Hospital
Authority:
China: Ethics Committee
Study ID:
rjyyxhk6056
NCT ID:
NCT01508520
Start Date:
December 2009
Completion Date:
December 2011
Related Keywords:
- Stomach Neoplasms
- early gastric cancer
- stomach neoplasms
- magnifying endoscopy
- narrow band imaging
- Neoplasms
- Stomach Neoplasms