Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

NCT ID: NCT02851264

Last Updated: 2016-08-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 360 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-10-31

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 .

Conditions

Early Esophageal Squamous Neoplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Optical enhancement technology examination

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.

No interventions assigned to this group

Eligibility Criteria

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;

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Vice president of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yanqing Li, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital of Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Jinan, Shandong, China

Countries

China

Central Contacts

Yanqing Li, MD,PhD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236

Other Identifiers

2016SDU-QILU-10

Identifier Type: -

Identifier Source: org_study_id