Diagnostic Value of Virtual Chromoendoscopy With Optical Enhancement Technology in Early Esophageal Squamous Neoplasia: A Prospective Comparative Study

Shandong University1 site in 1 country360 target enrollmentAugust 2016

ConditionsEarly Esophageal Squamous Neoplasia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Early Esophageal Squamous Neoplasia
Sponsor: Shandong University
Enrollment: 360
Locations: 1
Primary Endpoint: The detection rate of early esophageal squamous neoplasia by optical enhancement technology.
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aims of the present study：

To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

Detailed Description

Detection and differentiation of esophageal squamous neoplasia (ESN) are of value in improving patient outcomes.Optical enhancement technology can serves in the diagnosis of GI neoplasia. However, its performance in ESN has not yet been reported.The aims of the present study is: 1. To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia. 2. To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .

Registry

clinicaltrials.gov

Start Date

August 2016

End Date

October 2017

Last Updated

9 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Shandong University

Responsible Party

Principal Investigator

Yanqing Li

Vice president of Qilu Hospital

Shandong University

Eligibility Criteria

Inclusion Criteria

•Patients with high-risk factors for esophageal squamous cell carcinoma who meet any of follows：
•Long term living in the high incidence area of esophageal squamous cell carcinoma ；
•First degree relatives have a history of esophageal squamous cell carcinoma ；
•Previous history of esophageal lesions （ esophageal squamous neoplasia ）；
•The patients having a history of cancer；
•A long history of smoking ；
•A long history of drinking ；
•Having bad eating habits such as eating fast, hot diet, high salt diet, eating pickles.
•Patients aged between 40 to 74 years old.

Exclusion Criteria

•Having advanced esophageal carcinoma;
•After esophageal surgery or endoscopic treatment ;
•Known esophageal radiotherapy or chemotherapy ;
•Esophageal stenosis;
•Acute bleeding;
•A known allergy to iodine;
•Coagulopathy (prothrombin time \<50% of control, partial thromboplastin time \>50 seconds);
•Having food retention;
•Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
•Being pregnant or lactating;

Outcomes

Primary Outcomes

The detection rate of early esophageal squamous neoplasia by optical enhancement technology.

Time Frame: 12 months

The detection rate of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy.

Secondary Outcomes

The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.(12 months)
The observation time of optical enhancement and Lugol chromoendoscopy.(12 months)
The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.(12 months)