Clinical Trial: Characterization of the Neo-squamous Epithelial Barrier

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus

Brief Summary: To prospectively assess the functional aspects of the the esophageal squamous epithelial barrier and correlate this with tissue inflammation and intercellular space dilation in patients who have successfully completed endoscopic therapy for Barrett's Esophagus related metaplasia.

Detailed Summary:

The investigators will measure and correlate mucosal impedance (measured using a novel endoscopic mucosal impedance catheter), intercellular space as measured with transmission electron microscopy and tissue levels of prostaglandin E2 in patients undergoing surveillance following successful endoscopic therapy (defined as two negative endoscopic surveillance histology for intestinal metaplasia).

Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Research biopsies will also be obtained at these levels for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.


Sponsor: Mayo Clinic

Current Primary Outcome: Mucosal Impedance as measured by an endoscopic probe [ Time Frame: Up to one year ]

Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Tissue levels of prostaglandin E2 [ Time Frame: Up to one year ]
    Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.
  • Intracellular space [ Time Frame: Up to one year ]
    Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.


Original Secondary Outcome: Same as current

Information By: Mayo Clinic

Dates:
Date Received: February 1, 2017
Date Started: September 26, 2016
Date Completion: October 2018
Last Updated: March 7, 2017
Last Verified: March 2017