Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

Study Overview
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Brief Summary
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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
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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: 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 .

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

Conditions
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Early Esophageal Squamous Neoplasia

Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Optical enhancement technology examination<br>After routine examination by white-light endoscopy,the imaging mode will be switched to optical enhancement.Suspicious area will be recorded in detail. Then all enrolled patients will have their esophagus sprayed with iodine solution. Suspicious area will be also recorded in detail.After that biopsy specimens will be obtained respectively by forceps from each suspicious lesion recorded for histologic diagnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The detection rate of early esophageal squamous neoplasia by optical enhancement technology. | The detection rate of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia. | Patients will be prospectively recruited to evaluate the diagnostic sensitivity, specificity and accuracy of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy. | 12 months | 
| The different rate of adverse events between optical enhancement and Lugol chromoendoscopy. |  | 12 months | 
| The observation time of optical enhancement and Lugol chromoendoscopy. |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Early Esophageal Squamous Neoplasia, optical enhancement technology, virtual chromoendoscopy