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

NCT01360801 | Terminated

• 1 other identifier: 10-003234
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• Accuracy of Agreement Between Imaging and Histology

  The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.

  9 months

Secondary Outcomes (1)

• Presence of Residual Disease

  9 months

Eligibility Criteria

• Age: 18 Years - 88 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mayo Clinic: lead
• Olympus: collaborator

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Herbert C. Wolfsen,, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Mayo College of Medicine; Director of Endoscopy, Mayo Clinic Florida

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 26, 2011
• Study Start: February 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 10, 2014

Record last verified: 2014-04

Locations

US (1)