Barrett's EsophagusNCT02632682
Confocal Laser Endomicroscopy vs Conventional Histology for the Identification of Intestinal Metaplasia
An observational study of Barrett's Esophagus, run by Minnesota Institute for Minimally Invasive Surgery.
Trial summary
Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Barrett's Esophagus
- How many people
- 172 participants
- Where
- No sites listed yet
- Study dates
- Feb 2016to Sep 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: * Age >18 * Clinical diagnosis of GERD * Undergoing upper endoscopy for reflux evaluation
Who may be able to join
- Age >18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation
Who cannot join
- Age <18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation
About this study
Official title: Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy With Conventional Histology for the Identification of Specialized Intestinal Metaplasia
Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia
Read the detailed description
The incidence of esophageal adenocarcinoma has risen over 800% over the past several decades and is associated with a high mortality rate. Barrett's esophagus (BE) has been identified as the number one risk factor for the development of esophageal adenocarcinoma. Gastroesophageal reflux disease (GERD) has been identified as the major risk factor for development of BE. Current guidelines for BE diagnosis and surveillance, according to the Seattle protocol, include four-quadrant random biopsies at 2-cm intervals (1-cm intervals if suspected high grade intraepithelial neoplasia). This random biopsy protocol can be time-consuming, expensive, and prone to sampling error, as very little of the esophageal surface area is actually sampled. Probe-based confocal laser endomicroscopy (pCLE) generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Comparing pCLE with conventional histology for the identification of specialized intestinal metaplasia has the potential to result in a new standard of care for the diagnosis of BE. The aim of this study is to compare pCLE to traditional tissue biopsies for the diagnosis of BE.
A patient with GERD will be scheduled for upper endoscopy as part of routine evaluation. Routine endoscopy will be performed, including white light and narrow band imaging photo documentation. Probe-based confocal laser endomicroscopy will be performed at the gastroesophageal junction. Biopsies of columnar lined esophagus will then be taken in four quadrants starting at the squamocolumnar junction and proceeding in 1 cm segments to the gastroesophageal junction. Optical biopsy images will be reviewed immediately following endoscopy by endoscopist and later reviewed by blinded independent reviewer. Pathology specimens will be reviewed by a pathologist. The results of the optical biopsies obtained with probe-based confocal laser endomicroscopy will be compared with the pathology results.
- Conditions
- Barrett's Esophagus
- Keywords
- probe-based confocal laser endomicroscopy
- Medical subject headings
- Barrett Esophagus
What is being measured
The primary outcome is the main question the study is designed to answer.
Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.
Metrics for the study will include "positive" or "negative" for Barrett's esophagus.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2015 (estimated)
- Study startFeb 2016
- Primary completionAug 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Barrett's EsophagusStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minnesota Institute for Minimally Invasive Surgery
- Sponsor type
- University, hospital or other
- Collaborators
- The Oregon Clinic
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632682
- Sponsor's protocol ID
- CLE-08
- Status last verified
- Nov 2016
- First submitted
- 4 Dec 2015
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy With Conventional Histology for the Identification of Specialized Intestinal Metaplasia
- ClinicalTrials.gov ID
- NCT02632682
- Acronym / sponsor ID
- CLE-08
- Conditions
- Barrett's Esophagus
- Keywords
- probe-based confocal laser endomicroscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Minnesota Institute for Minimally Invasive SurgeryUniversity, hospital or other
- Collaborators
- The Oregon Clinic
- Study start
- Feb 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 17 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.
Real-time Diagnosis of Barrett's Esophagus: Comparing Confocal Laser Endomicroscopy with Conventional Histology for the Identification of Specialized Intestinal Metaplasia
Detailed description
The incidence of esophageal adenocarcinoma has risen over 800% over the past several decades and is associated with a high mortality rate. Barrett's esophagus (BE) has been identified as the number one risk factor for the development of esophageal adenocarcinoma. Gastroesophageal reflux disease (GERD) has been identified as the major risk factor for development of BE. Current guidelines for BE diagnosis and surveillance, according to the Seattle protocol, include four-quadrant random biopsies at 2-cm intervals (1-cm intervals if suspected high grade intraepithelial neoplasia). This random biopsy protocol can be time-consuming, expensive, and prone to sampling error, as very little of the esophageal surface area is actually sampled. Probe-based confocal laser endomicroscopy (pCLE) generates optical biopsies, providing physicians with microscopic images of tissue instantaneously and in a minimally invasive manner. Comparing pCLE with conventional histology for the identification of specialized intestinal metaplasia has the potential to result in a new standard of care for the diagnosis of BE. The aim of this study is to compare pCLE to traditional tissue biopsies for the diagnosis of BE.
A patient with GERD will be scheduled for upper endoscopy as part of routine evaluation. Routine endoscopy will be performed, including white light and narrow band imaging photo documentation. Probe-based confocal laser endomicroscopy will be performed at the gastroesophageal junction. Biopsies of columnar lined esophagus will then be taken in four quadrants starting at the squamocolumnar junction and proceeding in 1 cm segments to the gastroesophageal junction. Optical biopsy images will be reviewed immediately following endoscopy by endoscopist and later reviewed by blinded independent reviewer. Pathology specimens will be reviewed by a pathologist. The results of the optical biopsies obtained with probe-based confocal laser endomicroscopy will be compared with the pathology results.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- * Age >18 * Clinical diagnosis of GERD * Undergoing upper endoscopy for reflux evaluation
Key inclusion criteria (1 listed)
- Age >18; Clinical diagnosis of GERD; Undergoing upper endoscopy for reflux evaluation
Key exclusion criteria (1 listed)
- Age <18, Contraindication to receiving fluorescein, Inability to provide informed consent, History of esophageal ablation
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
Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus.
Time frame: 8 months
Metrics for the study will include "positive" or "negative" for Barrett's 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 2 Dec 2016.
- Individual participant dataSharing planned: No
Related trials for Barrett's Esophagus
RecruitingObservational study
Multicenter Prospective Cohort on Esophageal Endoscopic Submucosal Dissection
Superficial Esophageal Cancer, Oesophageal Adenocarcinoma
RecruitingPhase 4
Efficacy of Potassium-Competitive Acid Blockers in Barrett's Esophagus (PCAB BE Study)
Barrett Esophagus
RecruitingObservational study
"Less-is-more in Barrett-surveillance" Care Evaluation of Barrett's Patients With Low-Risk in Whom Endoscopic Surveillance is Stopped. The BLISS Project.
Barrett Esophagus, Barrett Esophagus Adenocarcinoma
Not yet recruitingObservational study
Lucid BE Biomarkers Study
Barrett's Esophagus, Barrett's Esophagus With Dysplasia
RecruitingObservational study
Impact of RFA on Esophageal Distensibility and Mucosal Impedance
Dysplastic Barrett's Esophagus, Radiofrequency Ablation
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 Barrett's Esophagus, run by Minnesota Institute for Minimally Invasive Surgery.
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 1 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 2 Dec 2016. 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?
Probe-based confocal laser endomicroscopy (pCLE) will be compared to standard histologic analysis in the evaluation of Barrett's esophagus. (time frame: 8 months). 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 2 Dec 2016.