Clinical Trial: Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Observational

Official Title: Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy

Brief Summary: Subjects presenting to UNC Hospitals for routine endoscopic surveillance examinations for current Barrett's Esophagus (BE) or after successful radiofrequency ablation (RFA) of dysplastic Barrett's Esophagus (BE) will be offered enrollment in the study. After informed consent, and the same day as the endoscopic procedure, the subject will undergo administration of the Cytosponge assay. The patient will then undergo routine endoscopic surveillance, using a standard Seattle biopsy surveillance protocol. The Cytosponge will be placed in fixative and shipped to the Fitzgerald laboratory at the University of Cambridge for processing according to their established protocols. Tissue biopsies will undergo standard processing and H&E staining, with assessment by expert gastrointestinal pathologists at UNC. The primary outcome variables will be sensitivity and specificity of the novel assay, compared against the gold standard of the presence of recurrent BE as detected by upper endoscopy with biopsies. Secondary outcomes include acceptability of the nonendoscopic assay to the patient (assessed by a standardized tool, the Impact of Events Scale, as well as a visual analogue scale), and likelihood of assay positivity as a function of amount of residual disease (as measured by Prague criteria).

Detailed Summary:

Esophageal Adenocarcinoma is a Lethal Cancer with a Rapidly Increasing Incidence. Barrett's Esophagus (BE) is the Strongest Risk Factor for Esophageal Adenocarcinoma. Endoscopic Ablation Induces Reversion of Barrett's Esophagus, and Decreases Progression of Disease. Unfortunately, data demonstrate a risk of recurrence of BE following successful eradication. Recent data published by the candidate and colleagues from the Ablation of Intestinal Metaplasia Containing Dysplasia (AIM Dysplasia) study demonstrate that approximately 25% of subjects who experience successful eradication of dysplastic BE will develop recurrent BE.

Therefore, following successful endoscopic ablation, patients receive ongoing endoscopic surveillance. More recently, a simple, non-endoscopic device, termed the Cytosponge, has been developed for endoscopic screening of subjects at risk for BE. Cytosponge demonstrated a sensitivity of 90% and a specificity of 94% for the detection of BE.

We expect these investigations to lead to a less costly, highly accurate, less invasive and more preferred screening paradigm for the large number of subjects who have undergone endoscopic ablative therapy.

The Cytosponge is a simple, non-endoscopic device developed for endoscopic screening of subjects at risk for Barrett's esophagus (BE) by investigators at the University of Cambridge in the U.K. The Cytosponge is an ingestible capsule enclosing a compressed spherical mesh sponge of 3 cm diameter, the center of which is attached to a string. The capsule and string are swallowed with water. The string is held at the mouth without tension by means of a cardboard tab attached to the string, and esophageal peristalsis and gravity move the capsule into the stomach. After 5 minutes (during which the capsule dissolves and the sp
Sponsor: University of North Carolina, Chapel Hill

Current Primary Outcome:

• Cytosponge Acceptability [ Time Frame: 7 days after Baseline ]
  Acceptability will be measured the Impact of Events Scale. This widely used scale was developed to assess the distress associated with a specific life event. It includes measures of both the intrusiveness of the event, and any avoidance responses by the subject in response to the event. The scale will be administrated both shortly after, and 7 days after, the sampling. In order to allow the subjects to have time to reflect on the experience and to compare with the EGD, the 7 day measurements will represent the primary acceptability outcome of the study. Secondary acceptability outcomes will include a visual analogue scale of acceptability of the Cytosponge, performed after the Cytosponge is administered. Also, the subject will be asked whether he/she would be willing to repeat the assay, and, assuming similar accuracy between Cytosponge and upper endoscopy, whether he/she would rather undergo surveillance by Cytosponge or standard esophagogastroduodenoscopy (EGD) with biopsies.
• Cytosponge Performance [ Time Frame: Baseline ]
  Operating characteristics (pathology findings, specimen quality) of the cytosponge will be assessed against a gold standard of upper endoscopy with biopsies for endoscopic surveillance in subjects with a history of successful radiofrequency ablation for dysplastic BE.

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of North Carolina, Chapel Hill

Dates:
Date Received: April 3, 2014
Date Started: October 2014
Date Completion: May 2019
Last Updated: May 16, 2017
Last Verified: May 2017