Endoscopic Tri-Modal Imaging in Patients With Barrett's Esophagus
Completed
Conditions studied: Barretts Esophagus, High Grade Dysplasia, Early Esophageal Adenocarcinoma
In brief
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.
Key facts
- Study ID
- NCT00586989
- Run by
- Mayo Clinic
- People needed
- 60
- Starts
- 2007-12-01
- Expected to finish
- 2010-09-01
- Last updated by the study team
- 2016-01-07
Who can join
Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Mayo Clinic — Jacksonville, Florida, United States
- Academic Medical Center — Amsterdam, Netherlands
Full record on ClinicalTrials.gov
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