Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

Early Esophageal Squamous Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02851264
• Other study ID #: 2016SDU-QILU-10
• Status: Not yet recruiting
• Phase: N/A
• First received: July 28, 2016
• Last updated: July 28, 2016
• Start date: August 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2016
• Source: Shandong University
• Contact: Yanqing Li, MD,PhD
• Phone: 86-531-82169236
• Email: liyanqing[@]sdu.edu.cn
• Is FDA regulated: No
• Health authority: China: National Health and Family Planning Commission
• Study type: Observational

Clinical Trial 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 .

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 360
• Est. completion date: October 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 74 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Early Esophageal Squamous Neoplasia
• Neoplasms

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.		12 months	Yes
Secondary	The observation time of optical enhancement and Lugol chromoendoscopy.		12 months	No