Histology Post-Endoscopic Eradication Therapy (EET)

Completed

• Conditions: Barrett Esophagus; Esophageal Reflux

• Registration Number: NCT03375060
• Lead Sponsor: Northwestern University

Brief Summary

This study is looking at a cohort of patients who have undergone treatment for Barrett's Esophagus (BE) and who have experienced complete eradication of the disease. The aim of the proposed study is to evaluate the histologic features of the neosquamous epithelium (NSE) following complete eradication of intestinal metaplasia (CE-IM) in patients undergoing routine surveillance biopsies and compare these data to a direct measure of reflux using 24hr pH impedance, to determine the correlation between histology and persistent reflux. These data will allow us to more accurately risk stratify patients for recurrence of BE following EET.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-02
• Study First Submitted: 2017-10-16
• Primary Completion: 2017-11-05
• Study Completion: 2017-11-05
• Status Verified: 2017-12
• Study First Submitted QC: 2017-12-11
• Last Update Submitted: 2017-12-11
• Study First Posted: 2017-12-15
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• • Patients who have undergone endoscopic eradication therapy and 24hr pH impedance testing as part of standard of care between 2009 and 2014.
• • Individuals who have signed a consent to be part of the Prospective Evaluation of Barrett's Esophagus Study population.

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Exclusion Criteria

• • Individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from the study.
• • Patient who were previously unable or unwilling to give consent to the Prospective Evaluation of Barrett's Esophagus Study will be excluded.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)	1 year	A composite histologic score made up of the following criteria: * Eosinophil infiltration (0: none, 1: scattered or focal, 2: diffuse or multifocal); * Dilated intercellular spaces (0: none, 0.5: intercellular spaces seen at 40x focal, 1: intercellular spaces seen at 40x diffuse, 1.5: intercellular spaces seen at 10x focal, 2: intercellular spaces seen at 10x diffuse); * Parakaratosis (0: absent, 2: present); * Ballooning degeneration (0: none, 1: focal, 2: extensive); * Basal cell hyperplasia (0: \<15% of total thickness, 1: 15-33% of total thickness, 1.5: 33-66% of total thickness, 2: \>66% of total thickness); * Columnar differentiation (0: no columnar mucosa present, 2: columnar mucosa adjacent to squamous); * Ulceration/erosion (0: absent, 1: present); Total possible score: 13

Secondary Outcome Measures

Name	Time	Method
24hr pH-impedance testing: Demeester score	1 year	Demeester score
24hr pH-impedance testing: percent acid reflux	1 year	Percent acid reflux
Correlation between histologic features and persistent reflux	1 year	If participants with abnormal 24hr pH-impedance testing, as determined by outcomes 2, 3, and 4, have greater mean scores for histologic criteria evaluated in outcome 1.
24hr pH-impedance testing: baseline impedance	1 year	Baseline impedance
Recurrence rate of intestinal metaplasia (Barrett's esophagus)	1 year	Recurrence rate of intestinal metaplasia in the overall cohort and the cohort with abnormal 24hr pH-impedance testing

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States