Clinical trial · Observational
Histology Post-Endoscopic Eradication Therapy (EET)
Optimizing Patient Outcomes Through Early Detection of Uncontrolled Acid Reflux After Endoscopic Therapy in Barrett's Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett Esophagus | — | UNRESOLVED | — |
| Esophageal Reflux | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Composite histologic score of neosquamous epithelium following endoscopic eradication therapy (EET)
- timeFrame
- 1 year
- description
- 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 (5)
- measure
- 24hr pH-impedance testing: percent acid reflux
- timeFrame
- 1 year
- description
- Percent acid reflux
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available