Gastroesophageal Reflux DiseaseNCT00886197
Diagnostic Efficacy of Narrow Band Imaging in Patients With Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Gastroesophageal Reflux Disease
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2007to Apr 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.
Who may be able to join
- Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old.
- Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.
Who cannot join
- Symptomatic reflux patients with apparent erosive esophagitis in conventional endoscopy.
- Symptomatic reflux patients with a history of using PPI in recent 4 months.
- Subjects with known allergy to PPI.
- Peptic ulcer disease
- Cancers of the esophagus, stomach, and duodenum
- Esophageal varices.
Show all 10Show fewer
- Active upper gastrointestinal bleeding within 7 days prior to enrollment
- Status after total or subtotal gastrectomy
- Use of anticoagulants or antiplatelets within one week prior to enrollment
- Subjects with bleeding tendency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Efficacy of Narrow Band Imaging (NBI) in Patients With Gastroesophageal Reflux Disease (GERD)
Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice for erosive patients with excellent therapeutic response, the majority of reflux patients can be classified with non-erosive reflux disease (NERD).Narrow-band imaging (NBI) is a novel, noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination. Based on the standard procedure of sequential conventional white-light, NBI, and magnified NBI, the investigators have validated the reliability of the diagnostic testing. The investigators will also enroll NERD patients to test their therapeutic response to rabeprazole. The investigators can find out the best strategy to identify the PPI responder.
Read the detailed description
Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice for erosive patients with excellent therapeutic response, the majority of reflux patients can be classified with non-erosive reflux disease (NERD).1 Not all of them demonstrate a favorable response to PPI treatment because the pathogenesis of NERD is in part associated with psychosomatic pathways.2 Their therapeutic response to PPI is unpredictable. Therefore, how to improve the diagnosis of reflux-induced mucosal damage under endoscopy is a worthwhile endeavor.
Minimal change esophagitis is commonly accepted as part of the spectrum of reflux esophagitis in Japan.3,4 This category is defined as "erythema without sharp demarcation, whitish turbidity, and/or invisibility of vessels due to these findings".3 Although the minimal change disease (MCD) can be recognized in a significant number of patients with reflux using endoscopy-first policy, the major drawback of this category from the Los Angeles system is due to a poor interobserver agreement (κ statistic = 0.2).
Narrow-band imaging (NBI) is a novel, noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination.5 This system is highly applicable in the detection of early-stage mucosal lesions, including oral cancer, Barrett's esophagus, gastric cancer, and colonic neoplasm.6-10 For the reflux patients we face on a daily basis, the NBI system has been proven to improve the intraobserver and interobserver reproducibilities in grading esophagitis with small erosive foci (improving overall κ value to 0.62 versus 0.45).11 Corresponding to the crowding of capillaries, inflamed mucosal breaks appear dark brown on NBI, which produces intense contrast against the normal squamous epithelium and the stomach mucosa. These properties may improve our ability to delineate the margins of small inflammatory foci. Based on this advantage, we plausibly hypothesize the use of this system may improve the description of MCD and enable the prediction of therapeutic response to PPI. Testing this hypothesis is the main goal of our study.
Aim of the Study To assess the clinical utility and therapeutic implications of NBI in evaluating reflux patients with minimal mucosal damage.
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- reflux, GERD
- Medical subject headings
- Gastroesophageal Reflux
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 |
|---|---|---|
| GERD | 1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic response to proton-pump inhibitor (PPI)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2009 (estimated)
- Study startSep 2007
- Primary completionApr 2009
- Study completionApr 2009
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.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yi-Chia Lee, MD,MSc, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00886197
- Sponsor's protocol ID
- 200707042R
- Status last verified
- Apr 2009
- First submitted
- 20 Apr 2009
- Last updated
- 22 Apr 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Efficacy of Narrow Band Imaging (NBI) in Patients With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT00886197
- Acronym / sponsor ID
- 200707042R
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- reflux, GERD
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 22 Apr 2009 (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.
Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice for erosive patients with excellent therapeutic response, the majority of reflux patients can be classified with non-erosive reflux disease (NERD).Narrow-band imaging (NBI) is a novel, noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination. Based on the standard procedure of sequential conventional white-light, NBI, and magnified NBI, the investigators have validated the reliability of the diagnostic testing. The investigators will also enroll NERD patients to test their therapeutic response to rabeprazole. The investigators can find out the best strategy to identify the PPI responder.
Detailed description
Gastroesophageal reflux disease (GERD) is a common disorder in Asia that includes erosive and non-erosive counterparts. The evaluation of intra-esophageal damage is of paramount importance because patients with erosive and those with non-erosive GERD have distinct manifestations and prognoses. Although proton-pump inhibitor (PPI) is the treatment of choice for erosive patients with excellent therapeutic response, the majority of reflux patients can be classified with non-erosive reflux disease (NERD).1 Not all of them demonstrate a favorable response to PPI treatment because the pathogenesis of NERD is in part associated with psychosomatic pathways.2 Their therapeutic response to PPI is unpredictable. Therefore, how to improve the diagnosis of reflux-induced mucosal damage under endoscopy is a worthwhile endeavor.
Minimal change esophagitis is commonly accepted as part of the spectrum of reflux esophagitis in Japan.3,4 This category is defined as "erythema without sharp demarcation, whitish turbidity, and/or invisibility of vessels due to these findings".3 Although the minimal change disease (MCD) can be recognized in a significant number of patients with reflux using endoscopy-first policy, the major drawback of this category from the Los Angeles system is due to a poor interobserver agreement (κ statistic = 0.2).
Narrow-band imaging (NBI) is a novel, noninvasive optical technique that adjusts reflected light to improve the contrast of capillary patterns compared with conventional illumination.5 This system is highly applicable in the detection of early-stage mucosal lesions, including oral cancer, Barrett's esophagus, gastric cancer, and colonic neoplasm.6-10 For the reflux patients we face on a daily basis, the NBI system has been proven to improve the intraobserver and interobserver reproducibilities in grading esophagitis with small erosive foci (improving overall κ value to 0.62 versus 0.45).11 Corresponding to the crowding of capillaries, inflamed mucosal breaks appear dark brown on NBI, which produces intense contrast against the normal squamous epithelium and the stomach mucosa. These properties may improve our ability to delineate the margins of small inflammatory foci. Based on this advantage, we plausibly hypothesize the use of this system may improve the description of MCD and enable the prediction of therapeutic response to PPI. Testing this hypothesis is the main goal of our study.
Aim of the Study To assess the clinical utility and therapeutic implications of NBI in evaluating reflux patients with minimal mucosal damage.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GERD | – | –1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old. 2. Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.
Key inclusion criteria (2 listed)
- Symptomatic reflux subjects who receive esophagogastroscopy, aged from 20 to 70 years old.
- Patients with typical reflux symptoms (heartburn and/or acid regurgitation) at least 3 times per week in recent 4 months.
Key exclusion criteria (10 listed)
- Symptomatic reflux patients with apparent erosive esophagitis in conventional endoscopy.
- Symptomatic reflux patients with a history of using PPI in recent 4 months.
- Subjects with known allergy to PPI.
- Peptic ulcer disease
- Cancers of the esophagus, stomach, and duodenum
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
Therapeutic response to proton-pump inhibitor (PPI)
Time frame: 14 days
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 22 Apr 2009.
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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.
Yi-Chia Lee, MD,MSc principal investigator
National Taiwan University Hospital
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 Gastroesophageal Reflux Disease, 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 2 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: finished, as of the sponsor's last update on 22 Apr 2009. 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 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?
Therapeutic response to proton-pump inhibitor (PPI) (time frame: 14 days). 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 22 Apr 2009.