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

NCT ID: NCT02968069

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-10

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Early Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Suspected gastric cancerous lesions

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

Group Type EXPERIMENTAL

NBI

Intervention Type DEVICE

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

Interventions

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NBI

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

Intervention Type DEVICE

Other Intervention Names

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Evis Lucera system (CV-260, Olympus Inc, Japan) high-definition colonoscopes (CF-H260AL, Olympus Inc, Japan) magnifying colonoscopes (CF-H260AZL, Olympus Inc, Japan)

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Putuo District Center Hospital

OTHER

Sponsor Role collaborator

Shanghai MCC worker hospital

UNKNOWN

Sponsor Role collaborator

Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Xiaobo Li

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaobo Li, MD.Ph.D

Role: PRINCIPAL_INVESTIGATOR

Departments of Gastroenterology and Clinical Laboratory, Shanghai Renji Hospital, Shanghai Jiaotong University School of Medicine, Shanghai,China,Shanghai Institute of Digestive Disease, Shanghai

Central Contacts

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Xiaobo Li, MD.Ph.D

Role: CONTACT

86-21-58752345

Other Identifiers

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2016-138k

Identifier Type: -

Identifier Source: org_study_id

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