High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy

Terminated

• Conditions: Barrett's Esophagus

• Registration Number: NCT01360801
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed Description

Information will be collected. Images will be taken.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-05-18
• Study First Submitted QC: 2011-05-25
• Study First Posted: 2011-05-26
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-08
• Last Update Posted: 2014-04-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• 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.

1. 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).
2. 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.)

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Exclusion Criteria

• 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.
• Pregnancy
• 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).

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of Agreement Between Imaging and Histology	9 months	The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.

Secondary Outcome Measures

Name	Time	Method
Presence of Residual Disease	9 months	Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States