Early Esophageal Squamous NeoplasiaNCT02851264
Diagnostic Value of Optical Enhancement Technology in Early Esophageal Squamous Neoplasia
An observational study of Early Esophageal Squamous Neoplasia, run by Shandong University at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Early Esophageal Squamous Neoplasia
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study.
Who may be able to join
- 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 ；
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- A long history of drinking ；
- Having bad eating habits such as eating fast, hot diet, high salt diet, eating pickles.
- Patients aged between 40 to 74 years old.
Who cannot join
- Having advanced esophageal carcinoma;
- After esophageal surgery or endoscopic treatment ;
- Known esophageal radiotherapy or chemotherapy ;
- Esophageal stenosis;
- Acute bleeding;
- A known allergy to iodine;
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- Coagulopathy (prothrombin time <50% of control, partial thromboplastin time >50 seconds);
- Having food retention;
- Severe hepatic ,renal, cardiovascular or metabolic dysfunction ;
- Being pregnant or lactating;
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Gastroenterology, Qilu Hospital, Shandong University
Jinan, Shandong, 250012
About this study
Official title: Diagnostic Value of Virtual Chromoendoscopy With Optical Enhancement Technology in Early Esophageal Squamous Neoplasia: A Prospective Comparative Study
The aims of the present study：
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- 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:
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .
- Conditions
- Early Esophageal Squamous Neoplasia
- Keywords
- Early Esophageal Squamous Neoplasia, optical enhancement technology, virtual chromoendoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 12 months
The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.
Measured: 12 months
The observation time of optical enhancement and Lugol chromoendoscopy.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Esophageal Squamous NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, MD,PhD, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02851264
- Sponsor's protocol ID
- 2016SDU-QILU-10
- Status last verified
- Jul 2016
- First submitted
- 28 Jul 2016
- Last updated
- 1 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Virtual Chromoendoscopy With Optical Enhancement Technology in Early Esophageal Squamous Neoplasia: A Prospective Comparative Study
- ClinicalTrials.gov ID
- NCT02851264
- Acronym / sponsor ID
- 2016SDU-QILU-10
- Conditions
- Early Esophageal Squamous Neoplasia
- Keywords
- Early Esophageal Squamous Neoplasia, optical enhancement technology, virtual chromoendoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 1 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of the present study：
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- 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:
- To investigate the diagnosing value of optical enhancement technology for early esophageal squamous neoplasia.
- To assess the detection rate of early esophageal squamous neoplasia by virtual chromoendoscopy with optical enhancement technology .
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients screened that fulfill the eligibility criteria at Qilu Hospital, Shandong University will be enrolled into the study.
Key inclusion criteria (9 listed)
- Patients with high-risk factors for esophageal squamous cell carcinoma who meet any of follows：
- Patients aged between 40 to 74 years old.
Key exclusion criteria (10 listed)
- Having advanced esophageal carcinoma;
- After esophageal surgery or endoscopic treatment ;
- Known esophageal radiotherapy or chemotherapy ;
- Esophageal stenosis;
- Acute bleeding;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
The diagnostic accuracy of optical enhancement technology on early esophageal squamous neoplasia.
Time frame: 12 months
The different rate of adverse events between optical enhancement and Lugol chromoendoscopy.
Time frame: 12 months
The observation time of optical enhancement and Lugol chromoendoscopy.
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yanqing Li, MD,PhD principal investigator
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Early Esophageal Squamous Neoplasia, run by Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanqing Li, MD,PhD (86-531-82169236, liyanqing@sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of early esophageal squamous neoplasia by optical enhancement technology. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2016.