Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

Shandong University

Status: Unknown

Conditions: Early Esophageal Squamous Neoplasia

Study type: Observational

Funder types: Other

Identifiers

NCT02851264

2016SDU-QILU-10

Details and patient eligibility

About

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 .

Full 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 .

Enrollment: 360 estimated patients

Sex: All

Ages: 40 to 74 years old

Volunteers: No Healthy Volunteers

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;

Trial design

360 participants in 1 patient group

Optical enhancement technology examination

Description:

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.