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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00586989 |
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.
Condition | Intervention |
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Barretts Esophagus High Grade Dysplasia Early Esophageal Adenocarcinoma |
Procedure: Upper endoscopy with biopsy |
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | 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 |
esophageal biopsies
Estimated Enrollment: | 60 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patient with Barrett's Esophagus with a history of High grade dysplasia or early esophageal adenocarcinoma
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Procedure: Upper endoscopy with biopsy
Endoscopy with biopsy 6 weeks after the initial endoscopy
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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.
Ages Eligible for Study: | 18 Years to 85 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
patients with barrett's esophagus or esophageal cancer referred for endoscopy
Inclusion Criteria:
Exclusion Criteria:
Contact: Louis M WongKeeSong, MD | 507-255-6930 | wong.louis@mayo.edu |
Contact: Kelly T Dunagan | 507-255-8692 | dunagan.kelly@mayo.edu |
United States, Florida | |
Mayo Clinic | Recruiting |
Jacksonville, Florida, United States, 32224 | |
Contact: Herbert C Wolfsen, MD 904-953-2221 wolfsen.herbert@mayo.edu | |
Netherlands | |
Academic Medical Center | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Contact: Jacques J Bergman, MD +31 20 5663556 j.j.bergman@amc.uva.nl |
Principal Investigator: | Louis M WongKeeSong, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Louis Michel WongKeeSong ) |
Study ID Numbers: | 07-003997, 07-003997 |
Study First Received: | December 21, 2007 |
Last Updated: | February 18, 2009 |
ClinicalTrials.gov Identifier: | NCT00586989 History of Changes |
Health Authority: | United States: Institutional Review Board |
Barrett's Esophagus Esophageal Cancer High Grade Dysplasia |
Gastrointestinal Diseases Esophageal Neoplasms Esophageal Cancer Carcinoma Digestive System Abnormalities Digestive System Diseases Esophageal Disorder |
Barrett Syndrome Barrett Esophagus Esophageal Diseases Adenocarcinoma Congenital Abnormalities Neoplasms, Glandular and Epithelial |
Neoplasms Digestive System Diseases Digestive System Abnormalities Neoplasms by Histologic Type Gastrointestinal Diseases |
Barrett Esophagus Esophageal Diseases Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |