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
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:
- ME-NBI is useful in distinguishing EGC from other gastric lesions
- ME-NBI is useful in further differential diagnosis among EGCs.
||Observational Model: Case-Only
Time Perspective: Prospective
||a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions
Biospecimen Retention: Samples Without DNA
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.
Samples after biopsy or resection are to be retained.
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||October 2011 (Final data collection date for primary outcome measure)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
patients with gastric lesions suspected of early gastric malignancy
- patients with gastric lesions which were detected by conventional screening endoscopy and suspected of early malignancy.
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01508520
||Xiaobo Li, MD. Ph.D
||Shanghai Ren Ji Hospital
||Xiaobo Li, Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Jiao Tong University
History of Changes
|Other Study ID Numbers:
|Study First Received:
||January 8, 2012
||January 11, 2012
||China: Ethics Committee
China: Ministry of Health
Keywords provided by Shanghai Jiao Tong University School of Medicine:
early gastric cancer
narrow band imaging
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on May 24, 2016
Digestive System Diseases
Digestive System Neoplasms
Neoplasms by Site