A Predictive Model Based on Narrow Band Imaging for Early Gastric Cancerous Lesions

Shanghai Jiao Tong University School of Medicine

Status: Not yet enrolling

Conditions: Early Gastric Cancer

Treatments: Device: NBI

Study type: Interventional

Funder types: Other

Identifiers

NCT02968069

2016-138k

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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300 participants in 1 patient group

Suspected gastric cancerous lesions

Experimental group

Description:

Magnifying endoscopy with NBI would be conducted for every patient included in our study

Treatment:

Device: NBI