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

This study has been terminated.
(enrollment moved very slowly which was not anticipated, and, funding issues)
Sponsor:
Collaborator:
Olympus
Information provided by (Responsible Party):
Herbert C. Wolfsen, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01360801
First received: May 18, 2011
Last updated: April 8, 2014
Last verified: April 2014
  Purpose

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
Barrett's Esophagus

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Accuracy of Agreement Between Imaging and Histology [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.


Secondary Outcome Measures:
  • Presence of Residual Disease [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.


Enrollment: 21
Study Start Date: February 2011
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Detailed Description:

Information will be collected. Images will be taken.

  Eligibility

Ages Eligible for Study:   18 Years to 88 Years
Genders Eligible for Study:   Both
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.

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01360801

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

No publications provided

Responsible Party: Herbert C. Wolfsen, Professor of Medicine, Mayo College of Medicine; Director of Endoscopy, Mayo Clinic Florida, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01360801     History of Changes
Other Study ID Numbers: 10-003234
Study First Received: May 18, 2011
Last Updated: April 8, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on September 16, 2014