Gastroesophageal Reflux DiseaseNCT01381991
The Efficacy of i-Scan for Detecting Reflux Esophagitis
A study testing i-scan in people with Gastroesophageal Reflux Disease and Reflux Esophagitis, run by Konkuk University Hospital at 1 site in South Korea.
Trial summary
Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, there were some limitation in diagnosis of GERD using endoscopy 1. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease, Reflux Esophagitis
- What is being tested?
- i-scan
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2010to Jun 2011
- Phase
- Interventional
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 to 80 years
- completed standard questionnaire including upper gastrointestinal symptoms
- underwent screening endoscopy
Who cannot join
- a patients with history of gastrointestinal surgery such as gastrectomy, fundoplication, or distal esophagectomy
- a patients were not able to record video clips during the period of examination of the gastro-esophageal junction
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Healthcare Center, Digestive Disease Center, Konkuk University Medical Center
Seoul
About this study
Official title: A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, there were some limitation in diagnosis of GERD using endoscopy
- More than half of patients with GERD reveal no visible abnormality on conventional endoscopy, it is possible that minute mucosal changes are underestimated by conventional endoscopy due to the limitation of visual ability
- In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity of mucosal injury can lead to inconsistency among interpreters. Interobserver agreement regarding diagnosis and classification of GERD using endoscopy is unsatisfactory to apply daily practice.
Read more
Thus, the development of a new method to define the intra-esophageal injury for use in daily practice is a worthwhile endeavor and developed, such as narrow-band imaging (NBI), Fuji Intelligent Chromoen-doscopy (FICE) and i-scan.
Among them, i-scan technology is the most recently developed image enhancing technology, which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE), and tone enhancement (TE).
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of reflux esophagitis and inter-observer agreement between endoscopists compared with conventional white light (WL) endoscopic examination.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a condition that develops when reflux of stomach contents causes troublesome symptoms and/or complications. It is the most frequent problem in upper gastrointestinal tract in outpatient clinic and contributes substantially to morbidity and to costs. Endoscopy is a widely used modality for the diagnosis and classification of GERD, and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, because more than half of patients with GERD reveal no visible abnormality on conventional endoscopy, it is possible that minute mucosal changes are underestimated by conventional endoscopy due to the limitation of visual ability.
In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity of mucosal injury can lead to inconsistency among interpreters. Asian gastroenterologists tend to diagnose endoscopically before they treat patients with symptoms suggestive of GERD and use the modified Los Angeles (LA) classification system that includes minimal changes as constituting a distinct grade of reflux esophagitis. In modified LA system, minimal change esophagitis is characterized by the mucosa such as erythema and/or whitish turbidity. However, because substantial overlap is noted between normal and minimal change, minimal change and LA class A, and LA class A and B, interobserver agreement regarding diagnosis and classification of reflux esophagitis is unsatisfactory to apply daily practice. Thus, the development of a new method to define the intra-esophageal injury for use in daily practice is a worthwhile endeavor.
Currently, new imaging technologies have applied in endoscopy to improve detecting and differentiating the subtle mucosal changes using digital contrast method such as narrow-band imaging (NBI), Fuji Intelligent Chromoen-doscopy (FICE) and i-scan. Among them, i-scan technology is the most recently developed image enhancing technology, which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE), and tone enhancement (TE). SE enhances light-dark contrast and CE adds blue color in relatively dark areas digitally, by obtaining luminance intensity data for each pixel. Applying SE and CE might allow detailed observation of subtle irregularities around the surface and TE analyzes the individual RGB components of a normal image and recombines the color frequencies of each component to enhance minute mucosal structures with subtle color changes.
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of reflux esophagitis and inter-observer agreement between endoscopists compared with conventional white light (WL) endoscopic examination
- Being tested
- i-scan
- Keywords
- Gastroesophageal Reflux Disease, Reflux esophagitis, i-scan
- Medical subject headings
- Gastroesophageal Reflux, Esophagitis, Peptic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
i-scanDevice
Also called Pentax EPKi processor and EG-2890i endoscopy
For all the study procedures, Pentax EPKi processor and high-resolution adult video endoscopes (EG-2890i; Pentax, Japan) with push button switch from WL to i-scan were used. I-scan consist of three modes of image enhancement including SE, CE, ant TE. For SE and CE, switching among three enhancement levels (2+,3+,4+) is possible. Although SE and CE modes can allow detailed observation of subtle mucosal irregularities, noise increases as enhancement becomes more intense. In addition, TE is possible to switch p (pit pattern), v (vessel), b (Barrett), e (esophagus), g (stomach) and c (colo-rectum) mode.
| Study group | Role | What they receive |
|---|---|---|
| i-scan-EGD | Experimental | Examination of GE junction using conventional WL as well as i-scan mode Receives: Device: i-scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare reflux esophagitis detection rate
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD of all enrolled patients
Measured: from 2 to 3months after completeion of patients' enrollement
Secondary outcomes (1)
To evaluate the interobserver agreement using modified LA classification
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD from 60 randomly selected enrolled patients
Measured: from 3 to 4 months after completeion of patients' enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startJul 2010
- Primary completionNov 2010
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux DiseaseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Konkuk University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Sung Noh Hong, M.D., Principal investigator, Konkuk University Medical Center,Konkuk University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381991
- Sponsor's protocol ID
- KUMCHSN03
- Status last verified
- Jun 2011
- First submitted
- 17 May 2011
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial of the Efficacy of i-Scan for Detecting Reflux Esophagitis
- ClinicalTrials.gov ID
- NCT01381991
- Acronym / sponsor ID
- KUMCHSN03
- Keywords
- Gastroesophageal Reflux Disease, Reflux esophagitis, i-scan
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Konkuk University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Jun 2011 (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.
Endoscopy is a widely used modality for the diagnosis and classification of Gastroesophageal reflux disease (GERD), and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, there were some limitation in diagnosis of GERD using endoscopy
- More than half of patients with GERD reveal no visible abnormality on conventional endoscopy, it is possible that minute mucosal changes are underestimated by conventional endoscopy due to the limitation of visual ability
- In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity of mucosal injury can lead to inconsistency among interpreters. Interobserver agreement regarding diagnosis and classification of GERD using endoscopy is unsatisfactory to apply daily practice.
Thus, the development of a new method to define the intra-esophageal injury for use in daily practice is a worthwhile endeavor and developed, such as narrow-band imaging (NBI), Fuji Intelligent Chromoen-doscopy (FICE) and i-scan.
Among them, i-scan technology is the most recently developed image enhancing technology, which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE), and tone enhancement (TE).
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of reflux esophagitis and inter-observer agreement between endoscopists compared with conventional white light (WL) endoscopic examination.
Detailed description
Gastroesophageal reflux disease (GERD) is a condition that develops when reflux of stomach contents causes troublesome symptoms and/or complications. It is the most frequent problem in upper gastrointestinal tract in outpatient clinic and contributes substantially to morbidity and to costs. Endoscopy is a widely used modality for the diagnosis and classification of GERD, and the extent of esophageal mucosal breaks on endoscopy can be assessed. However, because more than half of patients with GERD reveal no visible abnormality on conventional endoscopy, it is possible that minute mucosal changes are underestimated by conventional endoscopy due to the limitation of visual ability.
In addition of uncertainty in detecting mucosal breaks, uncertainty in describing severity of mucosal injury can lead to inconsistency among interpreters. Asian gastroenterologists tend to diagnose endoscopically before they treat patients with symptoms suggestive of GERD and use the modified Los Angeles (LA) classification system that includes minimal changes as constituting a distinct grade of reflux esophagitis. In modified LA system, minimal change esophagitis is characterized by the mucosa such as erythema and/or whitish turbidity. However, because substantial overlap is noted between normal and minimal change, minimal change and LA class A, and LA class A and B, interobserver agreement regarding diagnosis and classification of reflux esophagitis is unsatisfactory to apply daily practice. Thus, the development of a new method to define the intra-esophageal injury for use in daily practice is a worthwhile endeavor.
Currently, new imaging technologies have applied in endoscopy to improve detecting and differentiating the subtle mucosal changes using digital contrast method such as narrow-band imaging (NBI), Fuji Intelligent Chromoen-doscopy (FICE) and i-scan. Among them, i-scan technology is the most recently developed image enhancing technology, which consists of three modes of image enhancement, i.e. surface enhancement (SE), contrast enhancement (CE), and tone enhancement (TE). SE enhances light-dark contrast and CE adds blue color in relatively dark areas digitally, by obtaining luminance intensity data for each pixel. Applying SE and CE might allow detailed observation of subtle irregularities around the surface and TE analyzes the individual RGB components of a normal image and recombines the color frequencies of each component to enhance minute mucosal structures with subtle color changes.
Thus, the investigators examined the hypothesis that i-scan can improve the detection rate of reflux esophagitis and inter-observer agreement between endoscopists compared with conventional white light (WL) endoscopic examination
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| i-scan-EGD | Experimental | Device: i-scanExamination of GE junction using conventional WL as well as i-scan mode |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- aged 18 to 80 years
- completed standard questionnaire including upper gastrointestinal symptoms
- underwent screening endoscopy
Key exclusion criteria (2 listed)
- a patients with history of gastrointestinal surgery such as gastrectomy, fundoplication, or distal esophagectomy
- a patients were not able to record video clips during the period of examination of the gastro-esophageal junction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| i-scanAlso: Pentax EPKi processor and EG-2890i endoscopyFor all the study procedures, Pentax EPKi processor and high-resolution adult video endoscopes (EG-2890i; Pentax, Japan) with push button switch from WL to i-scan were used. I-scan consist of three modes of image enhancement including SE, CE, ant TE. For SE and CE, switching among three enhancement levels (2+,3+,4+) is possible. Although SE and CE modes can allow detailed observation of subtle mucosal irregularities, noise increases as enhancement becomes more intense. In addition, TE is possible to switch p (pit pattern), v (vessel), b (Barrett), e (esophagus), g (stomach) and c (colo-rectum) mode. | Device | i-scan-EGD |
Primary outcome
To compare reflux esophagitis detection rate
Time frame: from 2 to 3months after completeion of patients' enrollement
using videoclip (for endoscopic finding of GE junction) of WL-EGD vs. i-scan-EGD of all enrolled patients
1 secondary outcome
To evaluate the interobserver agreement using modified LA classification
Time frame: from 3 to 4 months after completeion of patients' enrollement
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2011.
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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.
Sung Noh Hong, M.D. principal investigator
Konkuk University Medical Center,Konkuk University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing i-scan in people with Gastroesophageal Reflux Disease and Reflux Esophagitis, run by Konkuk University Hospital at 1 site in South Korea.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jun 2011. 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 South Korea. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To compare reflux esophagitis detection rate (time frame: from 2 to 3months after completeion of patients' enrollement). 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 27 Jun 2011.