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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01360801
Recruitment Status : Terminated (enrollment moved very slowly which was not anticipated, and, funding issues)
First Posted : May 26, 2011
Last Update Posted : April 10, 2014
Information provided by (Responsible Party):
Herbert C. Wolfsen, 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.

Condition or disease
Barrett's Esophagus

Detailed Description:
Information will be collected. Images will be taken.

Study Type : Observational
Actual Enrollment : 21 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
Study Start Date : February 2011
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Accuracy of Agreement Between Imaging and Histology [ Time Frame: 9 months ]
    The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.

Secondary Outcome Measures :
  1. Presence of Residual Disease [ Time Frame: 9 months ]
    Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 88 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.

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.)

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01360801

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Principal Investigator: Herbert C. Wolfsen,, M.D. Mayo Clinic Florida

Responsible Party: Herbert C. Wolfsen, Professor of Medicine, Mayo College of Medicine; Director of Endoscopy, Mayo Clinic Florida, Mayo Clinic Identifier: NCT01360801     History of Changes
Other Study ID Numbers: 10-003234
First Posted: May 26, 2011    Key Record Dates
Last Update Posted: April 10, 2014
Last Verified: April 2014

Additional relevant MeSH terms:
Barrett Esophagus
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases