Non-Endoscopic Surveillance for Barrett's Esophagus Following Ablative Therapy
Condition: Barrett's Esophagus
MeSH terms: Barrett Esophagus
Study type: Interventional

Summary: 
      Subjects presenting to University of North Carolina at Chapel Hill (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 Hematoxylin and Eosin (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 description: 
      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 sponge is
      liberated), the sponge is withdrawn by gentle traction on the string and as it does so,
      collects cells from the lining of the esophagus. The sponge is placed in fixative, then the
      cells are pelleted, and processed into paraffin blocks. The pellets are immunostained with
      trefoil factor 3, which is interpreted simply as either positive or negative by the presence
      of any staining.
    

Intervention name(s): Cytosponge
Intervention type(s): Device
Intervention description(s): 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 gelatin capsule enclosing a compressed spherical polyurethane mesh sponge of 3 cm diameter, the center of which is attached to a string (Astralen, braided synthetic non-absorbable suture) (Figure 1). The capsule and string are swallowed with water. The string is held at the mouth without tension by means of a 7 cm cardboard tab attached to the string, and esophageal peristalsis and gravity move the capsule into the stomach. After 5 to 7 minutes (during which the gelatin capsule dissolves and the sponge is liberated), the sponge is withdrawn by gentle traction on the string and as it does so, collects cells from the lining of the esophagus. The sponge is placed in fixative for 48 hours, then the cells are pelleted, and processed into paraffin blocks
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Barrett's Esophagus; Radiofrequency Ablation