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Completed

NCT Number: NCT03375060

Histology Post-Endoscopic Eradication Therapy (EET)

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.

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Key information

Conditions

Esophageal Reflux Barrett Esophagus Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)

    Time frame: 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 outcomes

  1. 24hr pH-impedance testing: percent acid reflux

    Time frame: 1 year

    Percent acid reflux

  2. 24hr pH-impedance testing: baseline impedance

    Time frame: 1 year

    Baseline impedance

  3. 24hr pH-impedance testing: Demeester score

    Time frame: 1 year

    Demeester score

  4. Correlation between histologic features and persistent reflux

    Time frame: 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.

  5. Recurrence rate of intestinal metaplasia (Barrett's esophagus)

    Time frame: 1 year

    Recurrence rate of intestinal metaplasia in the overall cohort and the cohort with abnormal 24hr pH-impedance testing

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Dec 15, 2017
Registry last updated
Dec 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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