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Characterization of the Neo-squamous Epithelial Barrier

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ClinicalTrials.gov Identifier: NCT03077594
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : November 6, 2019
Sponsor:
Information provided by (Responsible Party):
Prasad G. Iyer, Mayo Clinic

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.

Condition or disease Intervention/treatment Phase
Barrett's Esophagus With Dysplasia Device: Mucosal Impedance Other: Research Biopsies Device: Volumetric Laser Endomicroscopy Not Applicable

Detailed 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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Characterization of the Neo-squamous Epithelial Barrier Following Successful Endoscopic Therapy in Barrett's Esophagus
Actual Study Start Date : September 26, 2016
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. Mucosal Impedance as measured by an endoscopic probe [ Time Frame: Up to two years ]
    Assess the mucosal impedance of neosquamous epithelium after successful treatment of Barrett's Esophagus.


Secondary Outcome Measures :
  1. Tissue levels of prostaglandin E2 [ Time Frame: Up to two years ]
    Assess the levels of prostaglandin E2 in neosquamous epithelium after successful treatment of Barrett's Esophagus.

  2. Intracellular space [ Time Frame: Up to two years ]
    Assess the intercellular space in neosquamous epithelium following successful treatment of Barrett's Esophagus with use of transmission electron microscopy.

  3. Volumetric Laser Endomicroscopy [ Time Frame: Up to two years ]
    Assess and measure precise thickness of and area of subsquamous structions underneath the neosquamous epithelium.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077594


Contacts
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Contact: Michele L Johnson, CCRP 507-255-8692 johnson.michele@mayo.edu

Locations
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United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Michele L Johnson, CCRP    507-255-8692    johnson.michele@mayo.edu   
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Griselda Compres    212-304-5595    Gmc2133@columbia.edu   
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Prasad Iyer, MD Mayo Clinic

Additional Information:
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Responsible Party: Prasad G. Iyer, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT03077594     History of Changes
Other Study ID Numbers: 16-005490
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Barrett Esophagus
Precancerous Conditions
Neoplasms
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases