Histology Post-Endoscopic Eradication Therapy (EET)

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03375060
• Other study ID #: STU00205592
• Status: Completed
• Phase: N/A
• First received: October 16, 2017
• Last updated: December 11, 2017
• Start date: August 2, 2017
• Est. completion date: November 5, 2017

Study information

• Verified date: December 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: November 5, 2017
• Est. primary completion date: November 5, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Esophageal Reflux
• Gastroesophageal Reflux

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24hr pH-impedance testing: percent acid reflux	Percent acid reflux	1 year
Secondary	24hr pH-impedance testing: baseline impedance	Baseline impedance	1 year
Secondary	24hr pH-impedance testing: Demeester score	Demeester score	1 year
Secondary	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
Secondary	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