Gastroesophageal Reflux DiseaseNCT01504971
Narrow-band Imaging, Autofluorescence Imaging and Gastroesophageal Reflux Disease
An observational study of Gastroesophageal Reflux Disease, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease
- What is being tested?
- symptom questionaire, pH monitoring and Tri-modal imaging endoscopy
- Type of treatment
- Surgery or procedure
- How many people
- 95 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Dec 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients presented with reflux symptoms in outpatient clinic of a general hospital.
- Inclusion criteria
- GERD symptom: heartburn or regurgitation (either one) at least 2 days a week
- Presence of symptom for longer than 1 month before screening
- Provision of written informed consent
- Exclusion criteria:
- Any known esophageal disease or disorder, other than reflux esophagitis
- Active or healing gastroduodenal ulcer (except scars)
- History of esophageal or gastric surgery.
- Clinically significant heart, lung, liver or kidney disease
- Allergy to proton-pump inhibitor
- Pregnancy
Trial locations and contacts
1 site in 1 country.
China1 site
Outpatient Department Building
Beijing, Beijing Municipality, 100853
About this study
Official title: Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease
Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).
Read the detailed description
GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).
NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD
- Conditions
- Gastroesophageal Reflux Disease
- Being tested
- symptom questionaire, pH monitoring, Tri-modal imaging endoscopy, rabeprazole
- Keywords
- Gastroesophageal Reflux;, Endoscopy;, Esophageal pH monitoring;, Narrow band imaging;, Autofluorescence imaging;, White light imaging;
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
symptom questionaireOther
Also called GERD symptom questionaire
GerdQ questionaire
pH monitoringProcedure or surgery
Also called Device was from Sierra Company
24-hour pH monitoring
Tri-modal imaging endoscopyProcedure or surgery
Also called Device was from Olympus Company
To investigate WLI,NBI and AFI
rabeprazoleDrug
Also called PPI therapy
10mg, bid, p.o.
| Study group | Role | What they receive |
|---|---|---|
| Gastroesophageal reflux disease (GERD) | Not described Receives: Other: symptom questionaire; Procedure: pH monitoring; Procedure: Tri-modal imaging endoscopy; Drug: rabeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.
Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month
Measured: 1 month
Secondary outcomes (3)
Association of Each Endoscopic Finding With Symptom Score
Symptom score is assessed by a self-reported questionnaire
Measured: 1 month
Association of Each Endoscopic Finding With pH Monitoring Result
Measured: 1 month
Association of Each Endoscopic Finding With Treatment Effect of PPI
Treatment effect of PPI is assessed by changes of symptom score
Measured: 2 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2012 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux DiseaseStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yunsheng Yang, Chinese PLA General Hospital
- Investigators
- Shuzhang Li, MD, Study chair, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01504971
- Sponsor's protocol ID
- 20111013-001
- Status last verified
- Aug 2015
- First submitted
- 4 Jan 2012
- Last updated
- 2 Sep 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3.
PubMed 18852068
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Narrow-band Imaging, Autofluorescence Imaging & White-light Imaging on Gastroesophageal Reflux Disease
- ClinicalTrials.gov ID
- NCT01504971
- Acronym / sponsor ID
- 20111013-001
- Conditions
- Gastroesophageal Reflux Disease
- Keywords
- Gastroesophageal Reflux;, Endoscopy;, Esophageal pH monitoring;, Narrow band imaging;, Autofluorescence imaging;, White light imaging;
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 6 Jan 2012 (estimated)
- Results
- Posted 2 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to compare the efficacy of narrow band imaging (NBI) and autofluorescence imaging (AFI) to distinguish subtle mucosal change related to acid reflux that is not visible in standard white light imaging (WLI) endoscopy, and help indicating the diagnosis of gastroesophageal reflux disease (GERD).
Detailed description
GERD is a common condition that develops when the reflux of gastric and/or duodenal contents causes troublesome symptoms with or without mucosal damage or complications. Despite the high prevalence of GERD in the general population, up to 60% of patients with reflux symptoms is insufficiently characterized as having normal endoscopic finding based on standard WLI endoscopy: non-erosive reflux diseases (NERD).
NBI is an optical-digital imaging technology that uses two specific narrow-banded shot wavelength lights (400-430 nm and 525-555 nm) instead of broad band white light. The NBI contrasts surface structure and vascular architecture of the superficial mucosa and facilitates evaluation of indistinct mucosal morphology. AFI produces real-time computed images of endoscopically detected autofluorescence emitted from endogenous fluorophores in the digestive tract (collagen, nicotinamide, adenine dinucleotide, flavin, and porphyrins) caused by light excitation. The AFI can identify lesions due to differences in tissue fluorescence properties that are not detectable by standard WLI. Hence, our hypothesis is that new endoscopic imaging i.e. NBI and AFI would help to identify subtle mucosal change which indicates the diagnosis of GERD
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastroesophageal reflux disease (GERD) | – | Other: symptom questionaire, Procedure: pH monitoring, Procedure: Tri-modal imaging endoscopy, Drug: rabeprazole |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented with reflux symptoms in outpatient clinic of a general hospital.
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 |
|---|---|---|
| symptom questionaireAlso: GERD symptom questionaireGerdQ questionaire | Other | Gastroesophageal reflux disease (GERD) |
| pH monitoringAlso: Device was from Sierra Company24-hour pH monitoring | Procedure or surgery | Gastroesophageal reflux disease (GERD) |
| Tri-modal imaging endoscopyAlso: Device was from Olympus CompanyTo investigate WLI,NBI and AFI | Procedure or surgery | Gastroesophageal reflux disease (GERD) |
| rabeprazoleAlso: PPI therapy10mg, bid, p.o. | Drug | Gastroesophageal reflux disease (GERD) |
Primary outcome
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom.
Time frame: 1 month
Patients with GERD symptom receive endoscopic tri-modal imaging within 1 month
3 secondary outcomes
Association of Each Endoscopic Finding With Symptom Score
Time frame: 1 month
Association of Each Endoscopic Finding With pH Monitoring Result
Time frame: 1 month
Association of Each Endoscopic Finding With Treatment Effect of PPI
Time frame: 2 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 18852068Fock KM, Teo EK, Ang TL, Tan JY, Law NM. The utility of narrow band imaging in improving the endoscopic diagnosis of gastroesophageal reflux disease. Clin Gastroenterol Hepatol. 2009 Jan;7(1):54-9. doi: 10.1016/j.cgh.2008.08.030. Epub 2008 Sep 3.
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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.
Shuzhang Li, MD study chair
Chinese PLA General 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 Chinese PLA General Hospital 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?
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 2 Sep 2015. 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?
Yes. Results are posted in the registry (first posted 2 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Diagnostic Ability of Each Endoscopic Finding for GERD Symptom. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01504971, which also lists 1 linked publication.
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 2 Sep 2015.