Histology Post-Endoscopic Eradication Therapy (EET)

Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus

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.

Study Overview

• Status: Completed
• Conditions: Barrett Esophagus; Esophageal Reflux

• Study Type: Observational
• Enrollment (Actual): 65

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have undergone EET and 24hr pH impedance testing as part of standard of care at Northwestern Memorial Hospital between 1/1/2009 and 12/31/2014 and who have enrolled in the Prospective Evaluation of Barrett's Esophagus database (NCT02634645).

Description

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.

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr pH-impedance testing: percent acid reflux	Percent acid reflux	1 year
24hr pH-impedance testing: baseline impedance	Baseline impedance	1 year
24hr pH-impedance testing: Demeester score	Demeester score	1 year
Correlation between histologic features and persistent reflux	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.	1 year
Recurrence rate of intestinal metaplasia (Barrett's esophagus)	Recurrence rate of intestinal metaplasia in the overall cohort and the cohort with abnormal 24hr pH-impedance testing	1 year

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Actual): November 5, 2017
• Study Completion (Actual): November 5, 2017

Study Registration Dates

• First Submitted: October 16, 2017
• First Submitted That Met QC Criteria: December 11, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 11, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Precancerous Conditions; Gastroesophageal Reflux; Barrett Esophagus
• Other Study ID Numbers: STU00205592

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No