a Prospective Study on the Efficacy of Magnifying Endoscopy With Narrow-band Imaging in Diagnosing Gastric Lesions

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01508520

Enrollment

146

Registered

2012-01-12

Start date

2009-12-31

Completion date

2011-12-31

Last updated

2012-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stomach Neoplasms

Keywords

early gastric cancer, stomach neoplasms, magnifying endoscopy, narrow band imaging

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
diagnosis accuracy of ME-NBI	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.

Outcome results