Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02851264

Enrollment

360

Registered

2016-08-01

Start date

2016-08-31

Completion date

2017-10-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Esophageal Squamous Neoplasia

Keywords

Early Esophageal Squamous Neoplasia, optical enhancement technology, virtual chromoendoscopy

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 .

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 74 Years

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;

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 different rate of adverse events between optical enhancement and Lugol chromoendoscopy.	12 months	—
The observation time of optical enhancement and Lugol chromoendoscopy.	12 months	—

Countries

China

Contacts

Primary ContactYanqing Li, MD,PhD

liyanqing@sdu.edu.cn86-531-82169236

Outcome results