- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00586989
Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus (ETMI)
January 5, 2016 updated by: Louis-Michel Wong Kee Song, Mayo Clinic
Endoscopic Tri-Modal Imaging for the Detection of High-Grade Dysplasia and Early Adenocarcinoma in Patients With Barrett's Esophagus: A Randomized Crossover Multi-center Study
This study is being done to determine if a new endoscope will help doctors identify pre-cancer or early cancer lesions in patients who have Barrett's esophagus.
This new endoscope allows the doctor to look at the lining of the esophagus in 3 different ways by modifying light.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Patients with Barrett's esophagus are advised to undergo periodic endoscopic surveillance with random biopsies in an attempt to identify high-grade dysplasia (HGD) or early adenocarcinoma (ACA) at a time when intervention can be curative.
This approach, however, can be time-consuming and is hindered by low sampling yield and random sampling error.
Endoscopic Tri-Modal Imaging (ETMI) is a novel diagnostic modality that encompasses three advanced imaging features in one system: high-resolution endoscopy (HRE), autofluorescence imaging (AFI) and narrow-band imaging (NBI).
HRE and AFI provide a bird's-eye view of 'red flag' areas which are then assessed by NBI for focused and more specific tissue characterization.
The aim of this prospective, multi-center study is to compare the diagnostic performance of ETMI with that of standard white-light endoscopy (WLE) for identifying high-grade dysplasia (HGD) and early adenocarcinoma (ACA) in BE.
A total of 84 BE patients will be recruited for the study and they will undergo both ETMI and WLE examinations in a randomized, crossover fashion.
Standard surveillance biopsies and ETMI-targeted biopsies will be performed.
The primary outcome will compare the number of patients and lesions with HGD or early ACA detected with WLE and ETMI.
It is anticipated that ETMI will enhance the detection of high-grade Barrett's lesions relative to WLE.
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Amsterdam, Netherlands, 1105 AZ
- Academic Medical Center
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Florida
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Jacksonville, Florida, United States, 32224
- Mayo Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients with barrett's esophagus or esophageal cancer referred for endoscopy
Description
Inclusion Criteria:
- Age > 18 years
- Prior diagnosis of BE, defined as the presence of columnar-lined epithelium in the distal tubular esophagus with specialised intestinal metaplasia on histological investigation
- Prior diagnosis of HGD or early ACA that was endoscopically inconspicuous according to the referring source
- A minimum Barrett's length of C>2M>2 or C<2M>4 according to the Prague C&M classification for the endoscopic appearance of BE
- Ability to provide written informed consent
Exclusion Criteria:
- Description of a visibly suspicious lesion within the Barrett's segment according to the referring source
- Presence of a type 0-I or type 0-III lesion, or a lesion that, according to the discretion of the endoscopist, does not allow delay in intervention for a period of 6 weeks (minimum interval between the two crossover endoscopies)
- Prior endoscopic therapy for Barrett's lesions, such as photodynamic therapy or endoscopic mucosal resection (EMR)
- Presence of esophagitis > Los Angeles grade A classification
- Presence of conditions precluding histological sampling of the esophagus (e.g., esophageal varices, coagulation disorders, anticoagulant therapy)
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
1
Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma
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Endoscopy with biopsy 6 weeks after the initial endoscopy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. The number of patients and the number of lesions with HGD or early ACA detected with WLE and ETMI 2. The number of patients with HGD and early ACA detected with targeted biopsies only with ETMI and WLE
Time Frame: 2 years
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2 years
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. The positive predictive value (PPV) of HRE and AFI 2. The reduction of false-positive findings after NBI (both the initial in vivo NBI assessment as well as later assessment based on still images)
Time Frame: 2 years
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2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Louis M WongKeeSong, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2007
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
September 1, 2010
Study Registration Dates
First Submitted
December 21, 2007
First Submitted That Met QC Criteria
January 4, 2008
First Posted (Estimate)
January 7, 2008
Study Record Updates
Last Update Posted (Estimate)
January 7, 2016
Last Update Submitted That Met QC Criteria
January 5, 2016
Last Verified
September 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-003997
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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