Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia

July 28, 2016 updated by: Yanqing Li, Shandong University

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

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 .

Study Overview

Status

Unknown

Conditions

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 .

Study Type

Observational

Enrollment (Anticipated)

360

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 74 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of early esophageal squamous neoplasia by optical enhancement technology.
Time Frame: 12 months
The detection rate of early esophageal squamous neoplasia by using optical enhancement and Lugol chromoendoscopy.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.
Time Frame: 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.
12 months
The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.
Time Frame: 12 months
12 months
The observation time of optical enhancement and Lugol chromoendoscopy.
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2016

Primary Completion (ANTICIPATED)

August 1, 2017

Study Completion (ANTICIPATED)

October 1, 2017

Study Registration Dates

First Submitted

July 28, 2016

First Submitted That Met QC Criteria

July 28, 2016

First Posted (ESTIMATE)

August 1, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016SDU-QILU-10

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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