Esophageal RefluxNCT03375060
Histology Post-Endoscopic Eradication Therapy (EET)
An observational study of Esophageal Reflux and Barrett Esophagus, run by Northwestern University at 1 site in United States.
Trial summary
This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophageal Reflux, Barrett Esophagus
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2017to 5 Nov 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone EET and 24hr pH impedance testing as part of standard of care at Northwestern Memorial Hospital between 1/1/2009 and 12/31/2014 and who have enrolled in the Prospective Evaluation of Barrett's Esophagus database (NCT02634645).
Who may be able to join
- - Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.
- - Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.
Who cannot join
- - Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.
- - Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus
This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.
- Conditions
- Esophageal Reflux, Barrett Esophagus
- Medical subject headings
- Gastroesophageal Reflux, Barrett Esophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)
A composite histologic score made up of the following criteria:
- Eosinophil infiltration (0: none, 1: scattered or focal, 2: diffuse or multifocal)
- Dilated intercellular spaces (0: none, 0.5: intercellular spaces seen at 40x focal, 1: intercellular spaces seen at 40x diffuse, 1.5: intercellular spaces seen at 10x focal, 2: intercellular spaces seen at 10x diffuse)
- Parakaratosis (0: absent, 2: present)
- Ballooning degeneration (0: none, 1: focal, 2: extensive)
- Basal cell hyperplasia (0: <15% of total thickness, 1: 15-33% of total thickness, 1.5: 33-66% of total thickness, 2: >66% of total thickness)
- Columnar differentiation (0: no columnar mucosa present, 2: columnar mucosa adjacent to squamous)
- Ulceration/erosion (0: absent, 1: present)
Total possible score: 13
Measured: 1 year
Secondary outcomes (5)
24hr pH-impedance testing: percent acid reflux
Percent acid reflux
Measured: 1 year
24hr pH-impedance testing: baseline impedance
Baseline impedance
Measured: 1 year
24hr pH-impedance testing: Demeester score
Demeester score
Measured: 1 year
Correlation between histologic features and persistent reflux
If participants with abnormal 24hr pH-impedance testing, as determined by outcomes 2, 3, and 4, have greater mean scores for histologic criteria evaluated in outcome 1.
Measured: 1 year
Recurrence rate of intestinal metaplasia (Barrett's esophagus)
Recurrence rate of intestinal metaplasia in the overall cohort and the cohort with abnormal 24hr pH-impedance testing
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start2 Aug 2017
- Primary completion5 Nov 2017
- Study completion5 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophageal RefluxStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Retrospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375060
- Sponsor's protocol ID
- STU00205592
- Status last verified
- Dec 2017
- First submitted
- 16 Oct 2017
- Last updated
- 15 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus
- ClinicalTrials.gov ID
- NCT03375060
- Acronym / sponsor ID
- STU00205592
- Conditions
- Esophageal Reflux, Barrett Esophagus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 2 Aug 2017 (actual)
- Primary completion
- 5 Nov 2017 (actual)
- Study completion
- 5 Nov 2017 (actual)
- First posted
- 15 Dec 2017 (actual)
- 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.
This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone EET and 24hr pH impedance testing as part of standard of care at Northwestern Memorial Hospital between 1/1/2009 and 12/31/2014 and who have enrolled in the Prospective Evaluation of Barrett's Esophagus database (NCT02634645).
Key inclusion criteria (2 listed)
- - Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.
- - Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.
Key exclusion criteria (2 listed)
- - Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.
- - Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded.
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
Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)
Time frame: 1 year
A composite histologic score made up of the following criteria: * Eosinophil infiltration (0: none, 1: scattered or focal, 2: diffuse or multifocal) * Dilated intercellular spaces (0: none, 0.5: intercellular spaces seen at 40x focal, 1: intercellular spaces seen at 40x diffuse, 1.5: intercellular spaces seen at 10x focal, 2: intercellular spaces seen at 10x diffuse) * Parakaratosis (0: absent, 2: present) * Ballooning degeneration (0: none, 1: focal, 2: extensive) * Basal cell hyperplasia (0: <15% of total thickness, 1: 15-33% of total thickness, 1.5: 33-66% of total thickness, 2: >66% of total thickness) * Columnar differentiation (0: no columnar mucosa present, 2: columnar mucosa adjacent to squamous) * Ulceration/erosion (0: absent, 1: present) Total possible score: 13
5 secondary outcomes
24hr pH-impedance testing: percent acid reflux
Time frame: 1 year
24hr pH-impedance testing: baseline impedance
Time frame: 1 year
24hr pH-impedance testing: Demeester score
Time frame: 1 year
Correlation between histologic features and persistent reflux
Time frame: 1 year
Recurrence rate of intestinal metaplasia (Barrett's esophagus)
Time frame: 1 year
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 15 Dec 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Esophageal Reflux and Barrett Esophagus, run by Northwestern University at 1 site 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 2 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 15 Dec 2017. 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 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?
Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET) (time frame: 1 year). 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 15 Dec 2017.