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Barrett's EsophagusNCT01976351

Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus

An observational study of Barrett's Esophagus, run by National Taiwan University Hospital at 1 site in Taiwan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and predict its invasiveness. There is potentially molecular change over the Barrett's esophagus in this Chinese population. Read more about this study

Who is it for?
Ages 20 to 80 years
Conditions the study is for
Barrett's Esophagus
How many people
51 participants
Where
1 siteTaiwan
Study dates
Sep 2009to Oct 2010
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 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients were eligible for the study if they were scheduled for endoscopic examination at the National Taiwan University Hospital and its Yun-Lin branch, because of a BE, with or without a previous history of dysplasia. Exclusion criteria included patients who are younger than 20 years of age or patients with esophageal or cardiac varices or pregnant women.

Who may be able to join

  • suspected or a history of Barrett's esophagus for endoscopic exam

Who cannot join

  • younger than 20 years of age
  • patients with esophageal or cardiac varices
  • pregnant women.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • National Taiwan University Hospital

    Taipei, 100

Other trials in Taiwan

About this study

Official title: Imaging Enhanced Endoscopy for the Screening of Barrett's Esophagus and Evaluation of Its Invasiveness in Patients With Gastroesophageal Reflux Disease

Imaging enhanced endoscopy can improve the efficacy of screening of Barrett's esophagus and predict its invasiveness. There is potentially molecular change over the Barrett's esophagus in this Chinese population.

To evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus and evaluation of invasiveness

Read the detailed description

Barrett ' s esophagus, defined as a pathological finding of metaplastic change of esophageal mucosa from squamous to columnar epithelium, is a tongue-like extension of salmon-colored mucosa from the gastroesophageal junction by endoscopy (1 2,3) . Endoscopic abnormalities suggestive of BE which has not been confirmed by histology, are defined as endoscopically suspected esophageal metaplasia (ESEM) (2). Barrett's esophagus is considered a precancerous lesion of esophageal adenocarcinoma (4 5) and it's mandatory for accurate diagnosis of BE. The pathogenesis of BE has also been closely associated with gastroesophageal reflux disease (6). In Western countries the reported prevalence of BE has varied from 0.9 to 4.5 % (3,7,8) in the general population and 6.3 to 13.6 % (9 - 12) in patients with GERD. For reliably rating differences of severity of endoscopically identified lesions among studies or quantify progression or regression of BE, International Working Group for the Classification of Oesophagitis (IWGCOA) proposed new classification of BE, the Prague C and M criteria (13) for defining the extent of BE based on the circumference (C) and maximum (M) of the lesion. This standard grading system could allow comparison of the severity of BE and aid in following the natural course of BE Image-enhanced endoscopy (IEE) compromises various means of enhancing contrast during endoscopy using dye, optical, and/or electronic methods IEE allows improved visualization of lesions and can be used to gain insight into the pathology of the lesion, Recent progress in optics and computerized processing of endoscopic images, such as narrow band image (NBI) and Fuji intelligent Chromoendoscopy (FICE), provide an optical and/or electronic enhancement of the mucosal structures. Most recently, the EPKi-processor (Pentax, Tokyo, Japan) developed i-Scan, a novel endoscopic post-processing light filter technology using delicate software algorithms with real-time image mapping technology, which can provide detailed analysis based on vessel (i-Scan V), pattern (i-Scan P), or surface architecture (i-Scan SE). Resolution of about 1.25 mega pixels per image could be provided by the computer-controlled digital processing. The SE-mode could be used for the identification of the morphological changes of esophageal mucosa. Accordingly, i-Scan e- and b-modes could be used to further evaluate the lesions, such as the regularity of vascular pattern and the presence of the abnormal vessels.

According to previous study (14), Ki67 and p53 immuno-histochemistry could reduce interobserver variation in assessment of Barrett's oesophagus. These IHC methods correlate with the severity of dysplasia very well and are useful supplementary prognostic markers In our study, we use the image enhanced endoscopy to observe the endoscopically suspected esophageal metaplasia and record it with Prague C and M criteria grading system. Immuno-histochemical staining was used as supplementary prognostic markers. Our aim is to evaluate the efficacy of imaging enhanced endoscopy for screening of Barrett's esophagus and evaluation of invasiveness.

Keywords
Barrett's esophagus, image-enhanced endoscopy
Medical subject headings
Barrett Esophagus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01976351
Study groupRoleWhat they receive
Barrett's esophagusPatients were eligible for the study if they were scheduled for endoscopic examination at the National Taiwan University Hospital and its Yun-Lin branch, because of a BE, with or without a previous history of dysplasia. Exclusion criteria included patients who are younger than 20 years of age or patients with esophageal or cardiac varices or pregnant women.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The relationship between the mucosal morphology by imaging enhanced endoscopy and the presence of high-grade intraepithelial neoplasia from non-dysplastic specialized intestinal metaplasia.

    Measured: Up to one month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Nov 2013 (estimated)
  2. Study startSep 2009
  3. Primary completionOct 2010
  4. Study completionOct 2010

Why it stopped: Insufficient research manpower

Resources

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
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01976351
Sponsor's protocol ID
200907036R
Status last verified
Oct 2013
First submitted
23 Oct 2013
Last updated
5 Nov 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Barrett's Esophagus, run by National Taiwan University Hospital at 1 site in Taiwan.

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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Nov 2013. 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 Taiwan. 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?

The study was stopped early (reason given: Insufficient research manpower). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relationship between the mucosal morphology by imaging enhanced endoscopy and the presence of high-grade intraepithelial neoplasia from non-dysplastic specialized intestinal metaplasia. (time frame: Up to one month). 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 5 Nov 2013.

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