Clinical trial NCT02851264: Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia
Official title: Diagnostic Value of Virtual Chromoendoscopy With Optical Enhancement Technology in Early Esophageal Squamous Neoplasia: A Prospective Comparative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Early Esophageal Squamous Neoplasia
Keywords: Early Esophageal Squamous Neoplasia
optical enhancement technology
virtual chromoendoscopy
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 360
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study.

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 .

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;

Primary outcomes:
measure: The detection rate of early esophageal squamous neoplasia by optical enhancement technology.
timeFrame: 12 months
Secondary outcomes:
measure: The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.
timeFrame: 12 months
measure: The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.
timeFrame: 12 months
measure: The observation time of optical enhancement and Lugol chromoendoscopy.
timeFrame: 12 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology, Qilu Hospital, Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Yanqing Li, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: