Barrett's EsophagusNOSENCT02498041
The Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Oesophagus
A study testing Transnasal Endoscopy, Office-based disposable transnasal endoscopy Endosheath and Standard upper GI endoscopy in people with Barrett's Esophagus and Dyspepsia, run by University of Cambridge.
Trial summary
This study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Barrett's Esophagus, Dyspepsia
- What is being tested?
- Transnasal Endoscopy, Office-based disposable transnasal endoscopy Endosheath and Standard upper GI endoscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Jul 2013
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 18 years and <75 years
- Patients who have given informed consent and who are capable of filling in the questionnaire.
- Patients requiring endoscopy for dyspepsia or follow-up evaluation and patients with a prior diagnosis of BE (defined as minimum Barrett's length of 2cm - according to M level of Prague C \& M classification) with specialized intestinal metaplasia on histological confirmation.
Who cannot join
- Previous upper GI tract or upper respiratory tract surgery or known upper GI tract abnormality (e.g. pharyngeal pouch).
- Coagulopathy or on anticoagulants
- Active or severe cardiopulmonary disease or liver disease
- Active GI bleeding
- Patients with alarm symptoms referred to the fast track service and any patient with dysphagia
- Patients requiring possible endoscopic therapy
- Patients with high-grade dysplasia or intramucosal carcinoma in BE requiring extensive evaluation and biopsy
About this study
Official title: Study to Compare the Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Esophagus Compared With Conventional Endoscopy to Inform a Future Multicentre Screening Trial
This study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy followed by the other procedure.
Read the detailed description
Background: The incidence of esophageal adenocarcinoma (EAC) has drammatically increased in the Western World in the last 30 years. Furthermore it often presents in the late stages and the prognosis remains poor with an overall 5-year survival of 10-15%. Early detection is possible since most cases of EAC develop from a precursor condition, Barrett's esophagus (BE), via a metaplasia-dysplasia-adenocarcinoma sequence. BE can be diagnosed with an upper GI endoscopy.
Un-sedated trans-nasal endoscopy (TNE) may be safer and less expensive than standard endoscopy (SE) for detecting BE. Emerging technologies require robust evaluation before routine use.
Objective: To evaluate the sensitivity, specificity, and acceptability of TNE in diagnosing BE compared with those of SE.
Design:Prospective, randomized, crossover study
Setting:Single, tertiary-care referral center.
Patients: patients with BE or those referred for diagnostic assessment will be enrolled consecutively .
Intervention: All patients will undergo TNE followed by SE or the reverse. Spielberger State-Trait Anxiety Inventory, short-form questionnaires, a visual analogue scale, and a single question addressing preference for endoscopy type will be administered.
Main Outcome Measurements: Diagnostic accuracy for BE and tolerability of TNE and SE.
The primary aim of this study is to evaluate the sensitivity and specificity of ultrathin endoscopy in diagnosing BE (using standardised endoscopic and histopathological criteria) compared with the gold standard white light conventional endoscopy.
The secondary aims include to assess the acceptability, optical quality and safety of the two interventions.
The study will consist of two phases. In a first large phase 80% of the target (90 patients) we will evaluate conventional TNE (Fujinon). In a second phase the remaining of the patients (25) will be evaluated with a disposable office-based system (Endosheath).
- Conditions
- Barrett's Esophagus, Dyspepsia
- Being tested
- Transnasal Endoscopy, Office-based disposable transnasal endoscopy Endosheath, Standard upper GI endoscopy, Esophageal biopsies
- Keywords
- Ultrathin Nasal Endoscopy, Barrett's Esophagus, Transnasal Endoscopy
- Medical subject headings
- Barrett Esophagus, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transnasal EndoscopyProcedure or surgery
Also called EG530N; Fujinon, Fujifilm, Valhalla, NY
Experimental procedure with transnasal endoscopy for the first 80% of the patients (n=90). The examination is limited to the esophagus and the proximal stomach.
Office-based disposable transnasal endoscopy EndosheathDevice
Also called Endosheath; Vision® Sciences, Inc, New York, USA
Experimental procedure with portable, disposable transnasal endoscopy for the last 20% of patients only (n=25). The examination is limited to the esophagus and the proximal stomach.
Standard upper GI endoscopyDevice
Also called Esophago-gastro-duodenoscopy
Upper GI endoscopy with standard gastroscope.
Esophageal biopsiesProcedure or surgery
Also called Research biopsies
2 research biopsies taken if endoscopic evidence of columnar-lined esophagus
| Study group | Role | What they receive |
|---|---|---|
| Transnasal Endoscopy | Experimental | Unsedated transnasal endoscopy with biopsies Receives: Procedure: Transnasal Endoscopy; Device: Office-based disposable transnasal endoscopy Endosheath; Procedure: Esophageal biopsies |
| Standard Gastroscopy | Active comparator | Standard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only Receives: Device: Standard upper GI endoscopy; Procedure: Esophageal biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endoscopic Diagnostic Accuracy for Barrett's esophagus
Sensitivity and specificity for detecting BE using ultrathin endoscopy when compared to gold standard conventional endoscopy will be calculated along with 95% Pearson-Clopper confidence intervals.
Measured: 2 weeks
Secondary outcomes (4)
Optical accuracy
Interobserver agreement for an endoscopic diagnosis of BE by different endoscopic interventions. The optical quality of ultrathin endoscopy will be compared with conventional endoscope by using a 10-cm VAS, where 10 is excellent and 0 is poor.
Measured: 2 weeks
Histological diagnosis of Barrett's esophagus
Yield of intestinal metaplasia in the biopsies taken at both procedures. The presence of intestinal metaplasia in research biopsies taken using ultrathin endoscopy will be compared with standard endoscopy.
Measured: 2 weeks
Patient acceptability
The overall acceptability for each procedure will be measured by State-Trait Anxiety inventory, Visual Analogue Scale and SF6 and the choice of procedure in future.
Measured: 12 weeks
Adverse events
Any adverse events reported by the patient in the week following the procedure
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startApr 2009
- Primary completionJul 2012
- Study completionJul 2013
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council
- Responsible party
- Principal investigator, Massimiliano di Pietro, MD, University of Cambridge
- Investigators
- Rebecca C Fitzgerald, MD, Principal investigator, University of CambridgeM. Kareem Shariff, MRCP, Principal investigator, University of CambridgeMassimiliano di Pietro, MD, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498041
- Sponsor's protocol ID
- UCambridge
- Acronym
- NOSE
- Status last verified
- Jul 2015
- First submitted
- 7 Jul 2015
- Last updated
- 15 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Compare the Efficacy and Patient Tolerance of Ultrathin Nasal Endoscopy to Detect Barrett's Esophagus Compared With Conventional Endoscopy to Inform a Future Multicentre Screening Trial
- ClinicalTrials.gov ID
- NCT02498041
- Acronym / sponsor ID
- NOSE / UCambridge
- Conditions
- Barrett's Esophagus, Dyspepsia
- Keywords
- Ultrathin Nasal Endoscopy, Barrett's Esophagus, Transnasal Endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Collaborators
- Medical Research Council
- Study start
- Apr 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 15 Jul 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.
This study evaluates the diagnostic accuracy, safety and acceptability of transnasal endoscopy (TNE) for a diagnosis of Barrett's esophagus (BE). This is a cross-over randomised trial, whereby patients receive two endoscopic procedures 2-4 weeks apart and will be randomised to receive either TNE or standard endoscopy followed by the other procedure.
Detailed description
Background: The incidence of esophageal adenocarcinoma (EAC) has drammatically increased in the Western World in the last 30 years. Furthermore it often presents in the late stages and the prognosis remains poor with an overall 5-year survival of 10-15%. Early detection is possible since most cases of EAC develop from a precursor condition, Barrett's esophagus (BE), via a metaplasia-dysplasia-adenocarcinoma sequence. BE can be diagnosed with an upper GI endoscopy.
Un-sedated trans-nasal endoscopy (TNE) may be safer and less expensive than standard endoscopy (SE) for detecting BE. Emerging technologies require robust evaluation before routine use.
Objective: To evaluate the sensitivity, specificity, and acceptability of TNE in diagnosing BE compared with those of SE.
Design:Prospective, randomized, crossover study
Setting:Single, tertiary-care referral center.
Patients: patients with BE or those referred for diagnostic assessment will be enrolled consecutively .
Intervention: All patients will undergo TNE followed by SE or the reverse. Spielberger State-Trait Anxiety Inventory, short-form questionnaires, a visual analogue scale, and a single question addressing preference for endoscopy type will be administered.
Main Outcome Measurements: Diagnostic accuracy for BE and tolerability of TNE and SE.
The primary aim of this study is to evaluate the sensitivity and specificity of ultrathin endoscopy in diagnosing BE (using standardised endoscopic and histopathological criteria) compared with the gold standard white light conventional endoscopy.
The secondary aims include to assess the acceptability, optical quality and safety of the two interventions.
The study will consist of two phases. In a first large phase 80% of the target (90 patients) we will evaluate conventional TNE (Fujinon). In a second phase the remaining of the patients (25) will be evaluated with a disposable office-based system (Endosheath).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transnasal Endoscopy | Experimental | Procedure: Transnasal Endoscopy, Device: Office-based disposable transnasal endoscopy Endosheath, Procedure: Esophageal biopsiesUnsedated transnasal endoscopy with biopsies |
| Standard Gastroscopy | Active comparator | Device: Standard upper GI endoscopy, Procedure: Esophageal biopsiesStandard endoscopy with biopsies. Patients will decide whether they prefer to have endoscopy with intrevenous sedation or with local anaesthetic only |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: > 18 years and <75 years
- Patients who have given informed consent and who are capable of filling in the questionnaire.
- Patients requiring endoscopy for dyspepsia or follow-up evaluation and patients with a prior diagnosis of BE (defined as minimum Barrett's length of 2cm - according to M level of Prague C \& M classification) with specialized intestinal metaplasia on histological confirmation.
Key exclusion criteria (7 listed)
- Previous upper GI tract or upper respiratory tract surgery or known upper GI tract abnormality (e.g. pharyngeal pouch).
- Coagulopathy or on anticoagulants
- Active or severe cardiopulmonary disease or liver disease
- Active GI bleeding
- Patients with alarm symptoms referred to the fast track service and any patient with dysphagia
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 |
|---|---|---|
| Transnasal EndoscopyAlso: EG530N; Fujinon, Fujifilm, Valhalla, NYExperimental procedure with transnasal endoscopy for the first 80% of the patients (n=90). The examination is limited to the esophagus and the proximal stomach. | Procedure or surgery | Transnasal Endoscopy |
| Office-based disposable transnasal endoscopy EndosheathAlso: Endosheath; Vision® Sciences, Inc, New York, USAExperimental procedure with portable, disposable transnasal endoscopy for the last 20% of patients only (n=25). The examination is limited to the esophagus and the proximal stomach. | Device | Transnasal Endoscopy |
| Standard upper GI endoscopyAlso: Esophago-gastro-duodenoscopyUpper GI endoscopy with standard gastroscope. | Device | Standard Gastroscopy |
| Esophageal biopsiesAlso: Research biopsies2 research biopsies taken if endoscopic evidence of columnar-lined esophagus | Procedure or surgery | Standard Gastroscopy, Transnasal Endoscopy |
Primary outcome
Endoscopic Diagnostic Accuracy for Barrett's esophagus
Time frame: 2 weeks
Sensitivity and specificity for detecting BE using ultrathin endoscopy when compared to gold standard conventional endoscopy will be calculated along with 95% Pearson-Clopper confidence intervals.
4 secondary outcomes
Optical accuracy
Time frame: 2 weeks
Histological diagnosis of Barrett's esophagus
Time frame: 2 weeks
Patient acceptability
Time frame: 12 weeks
Adverse events
Time frame: 1 week
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 Jul 2015.
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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.
Rebecca C Fitzgerald, MD principal investigator
University of Cambridge
M. Kareem Shariff, MRCP principal investigator
University of Cambridge
Massimiliano di Pietro, MD principal investigator
University of Cambridge
Questions about this trial
What is this clinical trial studying?
A study testing Transnasal Endoscopy, Office-based disposable transnasal endoscopy Endosheath and Standard upper GI endoscopy in people with Barrett's Esophagus and Dyspepsia, run by University of Cambridge.
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 3 inclusion and 7 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 Jul 2015. 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?
Endoscopic Diagnostic Accuracy for Barrett's esophagus (time frame: 2 weeks). 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 Jul 2015.