GERDNCT03824431
High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis
An observational study of GERD, run by University of Sao Paulo General Hospital.
Trial summary
Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for identification of abnormalities non detected in standard endoscopic exam. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- GERD
- What is being tested?
- Endoscopic esophageal biopsies
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 23 Jan 2014to 20 Nov 2018
- How long will I take part?
- 2 Days
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatients from the Gastroenterology Clinic (University of Sao Paulo)
Who may be able to join
- Outpatients aged 18 to 70 years
- Patients with symptoms typical of GERD, on at least two different days over a week, for a period of at least three consecutive months, and with conventional upper gastrointestinal endoscopy (UGE) without oesophageal changes, performed in the last 12 months.
Who cannot join
- Hiatal hérnia
- Ulcers of the upper digestive tract
- Drugs that interfere with the physiology of the esophagus
- Esophago-gastric surgeries
- Achalasia of the esophagus
- Esophagitis (erosive, eosinophilic, medicinal, infectious, non-erosive to conventional endoscopy)
Show all 21Show fewer
- Esophageal stricture
- Esophageal varices
- Clinical situations that prevent more detailed evaluation of the Escamo-colunar junction during endoscopy (psychomotor-agitation, cough)
- Barrett's Esophagus
- Esophageal diverticulum
- Atrophic gastritis
- Recent use of anti-inflammatories <30 days
- Systemic inflammatory / immune systemic diseases of the gastrointestinal tract
- Recent Infectious Diseases <30 days
- BMI (Body Mass Index) > 30 kg / m2
- Pregnant women
- Smoking
- Recent use of anticoagulants
- Comorbidities that may interfere with esophageal motility
- Recent use of PPI (Proton Pump Inhibitor) <7 days.
About this study
Official title: High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis-pHmetric , Esophageal Motility, Histological and Immunohistochemical Associative Findings With Endoscopic Microerosions
Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for identification of abnormalities non detected in standard endoscopic exam. The high definition endoscopy with NBI could achieve a more detailed mucosal evaluation, allowing distal esophageal microerosions identification.
The objective was validate the presence and the meaning of distal esophageal mucosal microerosions using high definition endoscopy and NBI through esophageal biopsy in gastroesophageal reflux disease symptomatic patients and the association with GERD physiopathology.
Seventy patients were selected from the gastroenterology outpatient clinic (University of Sao Paulo Hospital) Endoscopic evaluation was sequentially performed after the pHmetry and esophageal manometry. Esophageal mucosal biopsies were obtained following established protocol for histological and immunohistochemical study.
Read the detailed description
In this study the investigators focused the attention on patients with symptomatic GERD according to inclusion criteria and used high definition endoscopy with NBI in an attempt to increase the possibility of esophageal microerosion identification. The study was complemented with examinations of esophageal phmetry. During endoscopy, esophageal biopsies were obtained in patients with microerosions and controls (without microerosion). The collected material was evaluated by histopathological and immunohistochemical methods (interleukins-IL6, IL8 and IL1β) in an attempt to identify inflammatory alterations. The results of this investigation could contribute to the evaluation of microerosions as an early and significant abnormality with possible participation in the pathophysiology of GERD.
General objectives To validate the presence and clinical significance of endoscopic microerosions in patients submitted to esophageal mucosal biopsies, with typical symptoms of gastroesophageal reflux, using high definition endoscopy with (NBI), prolonged pHmetry, histopathological and immuno- histochemistry.
Specific objectives
- Validate the presence of microerosions in the distal esophagus, as found in high-resolution endoscopy with NBI, in patients with typical symptoms of Gastroesophageal Reflux Disease.
- Verify the association of microerosions in the distal esophagus in high-resolution endoscopy exams with NBI, with the manometric findings of esophageal perfusion manometry.
- To observe the changes in the prolonged pHmetry in patients with microerosions in the distal esophagus through high definition endoscopy with NBI.
- To evaluate the significance of the histological and immunohistochemical changes of tissue specimens obtained in esophageal biopsies of patients with microerosions in the distal esophagus, in high definition endoscopy with NBI.
This is a prospective, descriptive and cross-sectional study that included 90 patients, with GERD complaints. Seventy patients were selected as the object of study according to previously established inclusion and exclusion criteria. The selected patients were informed about their participation and signed an informed consent term. The histopathology and immunohistochemistry studies were carried out in the Department of Pathology of the same institution.
The study patients were evaluated after selection according to the inclusion and exclusion criteria on two occasions. On the first day, the examinations of esophageal manometry and phmetria were performed. The next day the pHmetry probe was removed and then the high definition endoscopy with NBI and the biopsies in the distal esophagus were performed. This approach facilitated patient adherence, especially in relation to logistics in performing the tests, and could represent more accurately the association of the tests performed. It was previously established that incomplete data from the exams would lead to the exclusion of the patient from the study.
- Conditions
- GERD
- Being tested
- Endoscopic esophageal biopsies
- Keywords
- Gastroesophageal reflux disease, Narrow Band Imaging, High definition endoscopy, Microerosions, Esophageal biopsy, Immunohistochemistry.
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic esophageal biopsiesDiagnostic test
Also called esophageal manometry, esophageal phmetry, esophageal biopsies
| Study group | Role | What they receive |
|---|---|---|
| patients with endoscopic microerosions | ==Patients with typical symptoms of Gastroesophageal Reflux Disease(GERD):
1- High resolution definition with NBI endoscopic findings of mucosal microerosions in distal esophagus .
. Receives: Diagnostic Test: Endoscopic esophageal biopsies | |
| patients without microerosions | 2- High resolution definition with NBI endoscopic without findings of mucosal microerosions in distal esophagus . Receives: Diagnostic Test: Endoscopic esophageal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
High definition endoscopy with digital chromoscopy
Presence or absence of microerosions in distal esophagus.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2019
- Study start23 Jan 2014
- Primary completion4 Nov 2016
- Study completion20 Nov 2018
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.
- More trials run by University of Sao Paulo 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
- Target duration
- 2 Days
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Tomas Navarro Rodriguez, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03824431
- Sponsor's protocol ID
- 39198813.4.0000.0068
- Status last verified
- Feb 2019
- First submitted
- 29 Jan 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High Definition Endoscopy With NBI. Contribution in Patients With Non-erosive Esophagitis-pHmetric , Esophageal Motility, Histological and Immunohistochemical Associative Findings With Endoscopic Microerosions
- ClinicalTrials.gov ID
- NCT03824431
- Acronym / sponsor ID
- 39198813.4.0000.0068
- Conditions
- GERD
- Keywords
- Gastroesophageal reflux disease, Narrow Band Imaging, High definition endoscopy, Microerosions, Esophageal biopsy, Immunohistochemistry.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- 23 Jan 2014 (actual)
- Primary completion
- 4 Nov 2016 (actual)
- Study completion
- 20 Nov 2018 (actual)
- First posted
- 31 Jan 2019 (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.
Most patients with symptomatic gastroesophageal reflux disease (GERD) have a normal upper gastrointestinal endoscopy. Attempts have been made to define new endoscopic techniques for identification of abnormalities non detected in standard endoscopic exam. The high definition endoscopy with NBI could achieve a more detailed mucosal evaluation, allowing distal esophageal microerosions identification.
The objective was validate the presence and the meaning of distal esophageal mucosal microerosions using high definition endoscopy and NBI through esophageal biopsy in gastroesophageal reflux disease symptomatic patients and the association with GERD physiopathology.
Seventy patients were selected from the gastroenterology outpatient clinic (University of Sao Paulo Hospital) Endoscopic evaluation was sequentially performed after the pHmetry and esophageal manometry. Esophageal mucosal biopsies were obtained following established protocol for histological and immunohistochemical study.
Detailed description
In this study the investigators focused the attention on patients with symptomatic GERD according to inclusion criteria and used high definition endoscopy with NBI in an attempt to increase the possibility of esophageal microerosion identification. The study was complemented with examinations of esophageal phmetry. During endoscopy, esophageal biopsies were obtained in patients with microerosions and controls (without microerosion). The collected material was evaluated by histopathological and immunohistochemical methods (interleukins-IL6, IL8 and IL1β) in an attempt to identify inflammatory alterations. The results of this investigation could contribute to the evaluation of microerosions as an early and significant abnormality with possible participation in the pathophysiology of GERD.
General objectives To validate the presence and clinical significance of endoscopic microerosions in patients submitted to esophageal mucosal biopsies, with typical symptoms of gastroesophageal reflux, using high definition endoscopy with (NBI), prolonged pHmetry, histopathological and immuno- histochemistry.
Specific objectives
- Validate the presence of microerosions in the distal esophagus, as found in high-resolution endoscopy with NBI, in patients with typical symptoms of Gastroesophageal Reflux Disease.
- Verify the association of microerosions in the distal esophagus in high-resolution endoscopy exams with NBI, with the manometric findings of esophageal perfusion manometry.
- To observe the changes in the prolonged pHmetry in patients with microerosions in the distal esophagus through high definition endoscopy with NBI.
- To evaluate the significance of the histological and immunohistochemical changes of tissue specimens obtained in esophageal biopsies of patients with microerosions in the distal esophagus, in high definition endoscopy with NBI.
This is a prospective, descriptive and cross-sectional study that included 90 patients, with GERD complaints. Seventy patients were selected as the object of study according to previously established inclusion and exclusion criteria. The selected patients were informed about their participation and signed an informed consent term. The histopathology and immunohistochemistry studies were carried out in the Department of Pathology of the same institution.
The study patients were evaluated after selection according to the inclusion and exclusion criteria on two occasions. On the first day, the examinations of esophageal manometry and phmetria were performed. The next day the pHmetry probe was removed and then the high definition endoscopy with NBI and the biopsies in the distal esophagus were performed. This approach facilitated patient adherence, especially in relation to logistics in performing the tests, and could represent more accurately the association of the tests performed. It was previously established that incomplete data from the exams would lead to the exclusion of the patient from the study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 2 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with endoscopic microerosions | – | Diagnostic Test: Endoscopic esophageal biopsies==Patients with typical symptoms of Gastroesophageal Reflux Disease(GERD): 1- High resolution definition with NBI endoscopic findings of mucosal microerosions in distal esophagus . . |
| patients without microerosions | – | Diagnostic Test: Endoscopic esophageal biopsies2- High resolution definition with NBI endoscopic without findings of mucosal microerosions in distal esophagus . |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatients from the Gastroenterology Clinic (University of Sao Paulo)
Key inclusion criteria (2 listed)
- Outpatients aged 18 to 70 years
- Patients with symptoms typical of GERD, on at least two different days over a week, for a period of at least three consecutive months, and with conventional upper gastrointestinal endoscopy (UGE) without oesophageal changes, performed in the last 12 months.
Key exclusion criteria (21 listed)
- Hiatal hérnia
- Ulcers of the upper digestive tract
- Drugs that interfere with the physiology of the esophagus
- Esophago-gastric surgeries
- Achalasia of the esophagus
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 |
|---|---|---|
| Endoscopic esophageal biopsiesAlso: esophageal manometry, esophageal phmetry, esophageal biopsies | Diagnostic test | patients with endoscopic microerosions, patients without microerosions |
Primary outcome
High definition endoscopy with digital chromoscopy
Time frame: 2 days
Presence or absence of microerosions in distal esophagus.
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 Feb 2019.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of GERD, run by University of Sao Paulo General Hospital.
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 21 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 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
High definition endoscopy with digital chromoscopy (time frame: 2 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 15 Feb 2019.