Histology Post-Endoscopic Eradication Therapy (EET)

NCT03375060 | Completed

• 1 other identifier: STU00205592
• Study Type: observational
• Target: 65
• Locations: 1 country
• Sites: 1

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.

Conditions

Esophageal Reflux; Barrett Esophagus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 24hr pH-impedance testing: percent acid reflux

  1 year

• 24hr pH-impedance testing: baseline impedance

  1 year

• 24hr pH-impedance testing: Demeester score

  1 year

• Correlation between histologic features and persistent reflux

  1 year

• Recurrence rate of intestinal metaplasia (Barrett's esophagus)

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Barrett Esophagus

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Precancerous Conditions; Neoplasms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2017
• First Posted: December 15, 2017
• Study Start: August 2, 2017
• Primary Completion: November 5, 2017
• Study Completion: November 5, 2017
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)