Characterization of the Neo-squamous Epithelial Barrier

NCT03077594 | Completed

• 1 other identifier: 16-005490
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 2

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

Conditions

Barrett's Esophagus With Dysplasia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Tissue levels of prostaglandin E2

  Up to two years

• Intracellular space

  Up to two years

• Volumetric Laser Endomicroscopy

  Up to two years

Study Arms (2)

Successfully ablated patients

Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy.

Device: Mucosal Impedance; Other: Research Biopsies

Successfully ablated patients - VLE

Mucosal impedance will be performed at the time of clinically indicated endoscopy. Research biopsies will be obtained during clinically indicated endoscopy. Volumetric laser endomicroscopy (VLE) will be done.

Device: Mucosal Impedance; Other: Research Biopsies; Device: Volumetric Laser Endomicroscopy

Interventions

Mucosal Impedance DEVICE

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.

Successfully ablated patients; Successfully ablated patients - VLE

Research Biopsies OTHER

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.

Successfully ablated patients; Successfully ablated patients - VLE

Volumetric Laser Endomicroscopy DEVICE

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.

Successfully ablated patients - VLE

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who have successfully completed endoscopic ablation (one endoscopy with no evidence of intestinal metaplasia).

You may qualify if:

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

You may not qualify if:

• Patients that have not achieved complete remission of intestinal metaplasia.
• Patients unable to consent.
• Pregnant women

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

Esophageal biopsies

Study Officials

• Prasad Iyer, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 1, 2017
• First Posted: March 13, 2017
• Study Start: September 26, 2016
• Primary Completion: November 1, 2019
• Study Completion: June 29, 2022
• Last Updated: January 18, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)