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Status unknownNCT02851264Updated Aug 1, 2016

Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

An observational study in Early Esophageal Squamous Neoplasia, sponsored by Shandong University. Status unknown at 1 site in China. Open to participants aged 40 Years to 74 Years. Per ClinicalTrials.gov, last updated 2016-08-01.

Sponsored by Shandong University · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
360
Ages
40 Years to 74 Years
Sex
All
01

Study 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 .
Read the 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 .
02

Conditions studied

  • Early Esophageal Squamous Neoplasia

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Keywords

  • Early Esophageal Squamous Neoplasia
  • optical enhancement technology
  • virtual chromoendoscopy
03

In context

Neoplasms

9,359 studies on the registry are indexed under Neoplasms; 2,486 are open to participants now.

This study's planned enrollment of 360 is above the median of 205 across 1,680 observational studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Shandong University is the lead sponsor of 284 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No
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.

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

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;
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
360 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 months

Secondary outcomes

  1. 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.

    Time frame: 12 months

  2. The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.

    Time frame: 12 months

  3. The observation time of optical enhancement and Lugol chromoendoscopy.

    Time frame: 12 months

07

Study locations

1 site
  • Department of Gastroenterology, Qilu Hospital, Shandong University
    Jinan, Shandong 250012, China
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 1, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02851264
Lead sponsor
Shandong University
Responsible party
Yanqing Li (Vice president of Qilu Hospital, Shandong University) — Principal investigator
First posted
Aug 1, 2016
Start date
Aug 2016
Primary completion
Aug 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Aug 1, 2016

Study contacts

Yanqing Li, MD,PhD
Contact
liyanqing@sdu.edu.cn
86-531-82169236
Yanqing Li, MD,PhD
principal investigator · Qilu Hospital of Shandong University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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