Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

• Conditions: Early Esophageal Squamous Neoplasia

• Registration Number: NCT02851264
• Lead Sponsor: Shandong University

Brief Summary

The aims of the present study：

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 .

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 .

Study Timeline

• Status Verified: 2016-07
• Study First Submitted: 2016-07-28
• Study First Submitted QC: 2016-07-28
• Last Update Submitted: 2016-07-28
• Study Start: 2016-08
• Study First Posted: 2016-08-01
• Last Update Posted: 2016-08-01
• Primary Completion: 2017-08
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

1. 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.

2. Patients aged between 40 to 74 years old.

Exclusion Criteria

1. Having advanced esophageal carcinoma;
2. After esophageal surgery or endoscopic treatment ;
3. Known esophageal radiotherapy or chemotherapy ;
4. Esophageal stenosis;
5. Acute bleeding;
6. A known allergy to iodine;
7. Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds);
8. Having food retention;
9. Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
10. Being pregnant or lactating;

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The detection rate of early esophageal squamous neoplasia by optical enhancement technology.	12 months	The detection rate of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy.

Secondary Outcome Measures

Name	Time	Method
The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.	12 months	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.
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

Trial Locations

Locations (1)

Department of Gastroenterology, Qilu Hospital, Shandong University; 🇨🇳 Jinan, Shandong, China