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NCT02968069 Clinical Trial

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

Early Gastric Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02968069
Other study ID # 2016-138k
Secondary ID
Status Not yet recruiting
Phase N/A
First received November 11, 2016
Last updated November 16, 2016
Start date December 2016
Est. completion date December 2019

Study information
Verified date November 2016
Source Shanghai Jiao Tong University School of Medicine
Contact Xiaobo Li, MD.Ph.D
Phone 86-21-58752345
Email lxb_1969@163.com
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 300
Est. completion date December 2019
Est. primary completion date December 2018
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
Shanghai Jiao Tong University School of Medicine Shanghai MCC worker hospital, Shanghai Putuo district Liqun hospital

Outcome
Type Measure Description Time frame Safety issue
Primary Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions 36 months No
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