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

Barrett's Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01360801
• Other study ID #: 10-003234
• Status: Terminated
• Phase: N/A
• First received: May 18, 2011
• Last updated: April 8, 2014
• Start date: February 2011
• Est. completion date: March 2014

Study information

• Verified date: April 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Information will be collected. Images will be taken.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 21
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 88 Years

Eligibility

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).

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus

Locations

Country	Name	City	State
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Olympus

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of Agreement Between Imaging and Histology	The accuracy of agreement between endoscopic imaging diagnosis compared with biopsy histology diagnosis.	9 months	No
Secondary	Presence of Residual Disease	Presence of any residual Barrett's disease at follow-up endoscopy after ablation / resection treatment.	9 months	No