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

Development and Validation of a Predictive Model for Early Gastric Cancerous Lesions Under Endoscopic Observation

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02968069

Enrollment

300

Registered

2016-11-18

Start date

2025-10-10

Completion date

2026-10-01

Last updated

2025-10-02

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

Conditions

Early Gastric Cancer

Brief summary

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

DEVICENBI

Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions	36 months

Contacts

Primary ContactXiaobo Li, MD.Ph.D

lxb_1969@163.com86-21-58752345

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026