GERDNCT02629081
Image-Enhanced Endoscopy (IEE) for Diagnosis of Non-Erosive Reflux Disease
An observational study of GERD, run by Loren Laine at 2 sites in United States.
Trial summary
When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD). Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- GERD
- How many people
- 90 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2015to Jul 2016
- 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 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Controls (participants scheduled for upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices and who do not have heartburn or other GERD symptoms and Cases (participants scheduled for upper endoscopy for heartburn or other GERD symptoms.)
Who may be able to join
- Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs
Who cannot join
- Patients who have evidence of erosive esophagitis under white-light endoscopy
- Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
- Patients unable or unwilling to sign informed consent
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Yale New Haven Hospital
New Haven, Connecticut, 06510
VACHS
West Haven, Connecticut, 06516
About this study
Official title: Image-Enhanced Endoscopy for the Diagnosis of Non-Erosive Reflux Disease: A Prospective Case-Control Trial
When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD).
Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming.
Read more
The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD.
Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.
Read the detailed description
Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive reflux disease (NERD), defined as heartburn documented to be associated with reflux on impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE) during initial endoscopy.
The investigators will examine the following characteristics for IEE sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these characteristics. The investigators will also look at abnormal morphology of intra-papillary capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and assess the identification of their presence using I-scan. Additionally, the investigators will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement.
IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).
Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.
- Conditions
- GERD
- Being tested
- Controls & Cases
- Keywords
- heartburn, GERD, NERD, non-erosive reflux disease
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Non-Erosive Reflux Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controls & CasesOther
All interventions are standard of care and both controls and cases will be treated the same. IEE results from controls and cases will be compared.
| Study group | Role | What they receive |
|---|---|---|
| Controls & Cases | Controls (participants without heartburn or other GERD symptoms undergoing standard upper endoscopy for the following: anemia, weight loss, diarrhea, and screening for esophageal varices) and Cases (participants with heartburn or other GERD symptoms undergoing standard endoscopy for heartburn or other GERD symptoms.) Receives: Other: Controls & Cases |
What is being measured
The primary outcome is the main question the study is designed to answer.
Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)
Measured: Once--at endoscopy
Secondary outcomes (2)
Presence or absence of micro-erosions identified by endoscopist using IEE
Measured: Once at endoscopy
Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)
Measured: Once at endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERDStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loren Laine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loren Laine, Yale University
- Investigators
- Loren Laine, MD, Principal investigator, Yale University, VACHS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02629081
- Sponsor's protocol ID
- HIC1503015486
- Other IDs
- 0005
- Status last verified
- Jul 2016
- First submitted
- 8 Dec 2015
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image-Enhanced Endoscopy for the Diagnosis of Non-Erosive Reflux Disease: A Prospective Case-Control Trial
- ClinicalTrials.gov ID
- NCT02629081
- Acronym / sponsor ID
- HIC1503015486
- Conditions
- GERD
- Keywords
- heartburn, GERD, NERD, non-erosive reflux disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Loren LaineUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 11 Dec 2015 (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.
When treating persistent heartburn from gastroesophageal reflux disease (GERD) that does not respond to conventional treatment (a class of medications called proton pump inhibitors), it is important to be able to distinguish between erosive GERD and non-erosive GERD (called NERD).
Currently the best method the investigators have to make this distinction is esophageal 24-hour pH and impedance testing. The test involves inserting a catheter into the esophagus through the nose and having the catheter maintained in this position for 24 hours This test is invasive, can be uncomfortable, and it is expensive and time consuming.
The investigators are hoping that image enhanced technology will identify characteristics that are found more commonly in patients with non-erosive GERD compared to controls and therefore provide evidence that may allow us to replace pH and impedance testing with the image enhanced endoscopy as the best way to diagnose NERD.
Participants will be either patients undergoing an upper endoscopy as part of their standard clinical evaluation for heartburn that does not respond to PPIs or patients undergoing standard clinical evaluation endoscopy for other reasons.
Detailed description
Evaluation of the utility of image-enhanced endoscopy (IEE) in the diagnosis of non-erosive reflux disease (NERD), defined as heartburn documented to be associated with reflux on impedance-pH testing in the absence of erosions on standard white-light endoscopy (WLE) during initial endoscopy.
The investigators will examine the following characteristics for IEE sensitivity, specificity, positive predictive values, and negative predictive value: squamo-columnar junction (SCJ) vascularity, micro-erosions, SCJ pit pattern, and combinations of these characteristics. The investigators will also look at abnormal morphology of intra-papillary capillary loops (IPCLS) using the newer generation Narrow Band Light (NBI-190 endoscopes and assess the identification of their presence using I-scan. Additionally, the investigators will examine real-time diagnostic yield of reflux diseases by IEE (in vivo diagnosis of reflux disease) and analyze obtained images and results to calculate inter-observer agreement.
IEE utilized will be commonly available I-scan (Pentax) and Narrow Band Imaging (Olympus).
Consecutive patients who meet eligibility criteria and are scheduled for upper endoscopy at locations specified in this record will be invited to participate.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controls & Cases | – | Other: Controls & CasesControls (participants without heartburn or other GERD symptoms undergoing standard upper endoscopy for the following: anemia, weight loss, diarrhea, and screening for esophageal varices) and Cases (participants with heartburn or other GERD symptoms undergoing standard endoscopy for heartburn or other GERD symptoms.) |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Controls (participants scheduled for upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices and who do not have heartburn or other GERD symptoms and Cases (participants scheduled for upper endoscopy for heartburn or other GERD symptoms.)
Key inclusion criteria (1 listed)
- Patients scheduled for an upper endoscopy for anemia, weight loss, diarrhea, or screening for esophageal varices without heartburn or other GERD symptoms and patients scheduled for upper endoscopy for heartburn not resolving with PPIs
Key exclusion criteria (3 listed)
- Patients who have evidence of erosive esophagitis under white-light endoscopy
- Patients with Barrett's esophagus or esophageal malignancy on prior or current endoscopy
- Patients unable or unwilling to sign informed consent
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 |
|---|---|---|
| Controls & CasesAll interventions are standard of care and both controls and cases will be treated the same. IEE results from controls and cases will be compared. | Other | Controls & Cases |
Primary outcome
Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE)
Time frame: Once--at endoscopy
2 secondary outcomes
Presence or absence of micro-erosions identified by endoscopist using IEE
Time frame: Once at endoscopy
Squamo-columnar junction pit pattern (graded as round or non-round by endoscopist using IEE)
Time frame: Once at endoscopy
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 12 Jul 2016.
- Individual participant dataSharing planned: Undecided
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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.
Loren Laine, MD principal investigator
Yale University, VACHS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by Loren Laine at 2 sites in United States.
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: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Squamo-columnar junction vascularity (graded as present or absent by endoscopist using IEE) (time frame: Once--at endoscopy). 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 12 Jul 2016.