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.
Sponsor:
Collaborator:
Olympus
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01360801
First received: May 18, 2011
Last updated: January 23, 2013
Last verified: January 2013

May 18, 2011
January 23, 2013
February 2011
October 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01360801 on ClinicalTrials.gov Archive Site
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.
Presence of Residual Disease [ Time Frame: 9 months ] [ Designated as safety issue: No ]
Presense of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.
Not Provided
Not Provided
 
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy
High Definition White Light Endoscopy and Narrow Band Imaging for the Assessment of Barrett's Disease After Endoscopic Therapy

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.

Information will be collected. Images will be taken.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Men and women (not pregnant) presenting to the GI Lab for Upper Endoscopy. Child-bearing potential not excluded.

Barrett's Esophagus
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
300
October 2013
October 2013   (final data collection date for primary outcome measure)

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).
Both
18 Years to 88 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01360801
10-003234
No
Herbert C. Wolfsen, M.D., Mayo Clinic
Mayo Clinic
Olympus
Principal Investigator: Herbert C. Wolfsen,, M.D. Mayo Clinic Florida
Mayo Clinic
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP