Histology Post-Endoscopic Eradication Therapy (EET)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03375060

Enrollment

Registered

2017-12-15

Start date

2017-08-02

Completion date

2017-11-05

Last updated

2017-12-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Barrett Esophagus, Esophageal Reflux

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
24hr pH-impedance testing: percent acid reflux	1 year	Percent acid reflux
24hr pH-impedance testing: baseline impedance	1 year	Baseline impedance
24hr pH-impedance testing: Demeester score	1 year	Demeester score
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.
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

Countries

United States

Outcome results