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

Primary Purpose

Early Gastric Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

NBI

About this trial

This is an interventional diagnostic trial for Early Gastric Cancer

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Suspected gastric cancerous lesions

Arm Description

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

Outcomes

Primary Outcome Measures

Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions

Secondary Outcome Measures

Full Information

NCT ID

NCT02968069

First Posted

November 11, 2016

Last Updated

November 16, 2016

Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Putuo district Liqun hospital, Shanghai MCC worker hospital

1. Study Identification

Unique Protocol Identification Number

NCT02968069

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Unknown status

Study Start Date

December 2016 (undefined)

Primary Completion Date

December 2018 (Anticipated)

Study Completion Date

December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Shanghai Jiao Tong University School of Medicine

Collaborators

Shanghai Putuo district Liqun hospital, Shanghai MCC worker hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Early Gastric Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Suspected gastric cancerous lesions

Arm Type

Experimental

Arm Description

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

Intervention Type

Device

Intervention Name(s)

NBI

Other Intervention Name(s)

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

Intervention Description

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

Primary Outcome Measure Information:

Title

Accuracy of the diagnostic model in histological prediction of gastric cancerous lesions

Time Frame

36 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xiaobo Li, MD.Ph.D

Phone

86-21-58752345

lxb_1969@163.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Xiaobo Li, MD.Ph.D

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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

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