A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NBI.
- Who it may be relevant to
- Registry conditions: Early Gastric Cancer. Basic parameters: 20 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation
Overview
Without high diagnostic efficacy of endoscopic forceps biopsy (EFB) and with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, it is urgent to improve diagnostic efficacy for gastric cancerous lesions.The investigators will conduct a study to develop and validate a diagnostic model based on NBI for early gastric cancerous lesions under endoscopic observation.
Detailed description
Endoscopic forceps biopsy (EFB) is considered the gold standard and most commonly used for histological diagnosis of gastric epithelial neoplasia before proper management.Many studies have shown that there exist considerable discrepancies between EFB and subsequently resected specimens with discrepancy rate of 27.1-44.5%. On the other hand, with low diagnostic efficacy of narrow band imaging (NBI) in novice endoscopists and endoscopists of community hospitals in China, not higher diagnostic accuracy of gastric cancerous lesions could be observed. Here, the investigators will conduct a study to develop and validate a diagnostic model based on narrow band imaging for early gastric cancerous lesions under endoscopic observation, trying to improve overall diagnostic efficacy for gastric cancerous lesions.
Interventions
- Device NBI
Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.
Primary outcome measures
- Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions [Time frame: 36 months]
Eligibility criteria
Inclusion criteria
- Suspected of having a cancerous lesions
- The age of patients is from 40-80 years
- Patients must undergo esophagogastroduodenoscopy
Exclusion criteria
- Clinical diagnosis of advanced gastric cancer
- Acute upper gastrointestinal bleeding
- Severe systemic diseases
- Refuse to attend the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT02968069 · 2016-138k