High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
This study is enrolling participants by invitation only.
Information provided by:
First received: May 18, 2011
Last updated: January 23, 2013
Last verified: January 2013
The investigators seek to test the hypothesis that the improved version of high definition white light endoscopes and Narrow Band Imaging (NBI) are more accurate in detecting residual Barrett's Metaplasia and Dysplasia disease after previous resection or ablation treatments than current versions of these endoscopes.
||Observational Model: Case-Only
Time Perspective: Prospective
||High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
Primary Outcome Measures:
Secondary Outcome Measures:
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||October 2013 (Final data collection date for primary outcome measure)
Information will be collected. Images will be taken.
|Ages Eligible for Study:
||18 Years to 88 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.
- Age 18 years and older
- Patients with Barrett's esophagus (BE) dysplasia as the original indication for treatment
- Undergoing any type of endoscopic BE resection or ablation treatment including RFA, cryotherapy, photodynamic therapy, or EMR, or combinations of these.
- <1cm of circumferential, peninsular, or island-type BE on prior endoscopy or ablation
- Ability to provide written, informed consent
Deferral Criteria: This category is for patients in two specific situations, 1) Erosive esophagitis, and, 2) presence of a nodule suspicious for the presence of neoplasia.
- Erosive esophagitis: patients found to have erosive esophagitis, will be deferred for up to 3 months from their Index study procedure, to permit more aggressive medical therapy to heal the erosive esophagitis. After healing, the Index study procedure will be performed up to 3 months later, and the follow-up endoscopy (and study closure) performed 3 to 6 months after that (total of no more than 9 months).
- Presence of nodule suspicious for neoplasia: for patients found to have such nodular lesions, the Index study procedure will be deferred for 3 months, while Endoscopic Mucosal Resection is performed and subsequently heals.
Note: Only one deferral per patient is permitted, and this one deferral is allowed only for these specific criteria. The end of the study will be defined by the time of follow-up of the last patient who was not deferred; any deferred patients who have not completed follow-up procedures by that time, may miss their follow-up visit as part of the study. (This is to prevent the possibility of delaying the close of the study due to deferral of a procedure late in the study.)
- Current participation in another clinical study
- Complete eradication of BE documented by biopsies in 3 or more previous endoscopic procedures performed after resection/ablation
- Inability to obtain biopsies due to anticoagulation, varices, etc.
- Worse than Grade C erosive esophagitis
- Less than 3 weeks from previous endoscopy with biopsy or 6 weeks from previous endoscopic therapy (ablation or resection).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01360801
|Jacksonville, Florida, United States, 32224 |
||Herbert C. Wolfsen,, M.D.
||Mayo Clinic Florida
No publications provided
||Herbert C. Wolfsen, M.D., Mayo Clinic
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 18, 2011
||January 23, 2013
||United States: Institutional Review Board
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 05, 2013
Digestive System Abnormalities
Digestive System Diseases