Characterization of the Neo-squamous Epithelial Barrier

Barrett's Esophagus With Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077594
• Other study ID #: 16-005490
• Status: Completed
• Start date: September 26, 2016
• Est. completion date: June 29, 2022

Study information

• Verified date: January 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 radiofrequency ablation versus balloon cryotherapy for Barrett's Esophagus related metaplasia.

Description:

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. Research biopsies will also be obtained for measurement of tissue levels of prostaglandin E2 and intracellular space with transmission electron microscopy.

Volumetric laser endomicroscopy will measure the precise thickness of and area of subsquamous structures underneath the neosquamous epithelium.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: June 29, 2022
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Adults (age 18-90) who underwent an ablative program for BE

Exclusion Criteria:

• Patients that have not achieved complete remission of intestinal metaplasia.

• Patients unable to consent.

• Pregnant women

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus With Dysplasia

Intervention

Device:
• Mucosal Impedance
Aim 1: 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. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

Other:
• Research Biopsies
Aim 1: Research biopsies will be obtained at 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. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

Device:
• Volumetric Laser Endomicroscopy
Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mucosal Impedance as measured by an endoscopic probe	Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.	Up to two years
Secondary	Tissue levels of prostaglandin E2	Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.	Up to two years
Secondary	Intracellular space	Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.	Up to two years
Secondary	Volumetric Laser Endomicroscopy	Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.	Up to two years

External Links

•   Mayo Clinic Clinical Trials