Phase 2
N=45
The Impact of Adjuvant Liquid Alginate on Endoscopic Ablation Therapy of Complicated Barrett's Esophagus
Barretts Esophagus With Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT03193216 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Mar 2023
Primary outcome: Primary: Percentage of Patients With Successful Eradication — 45.5; 38.1; 36.4; 19.04 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alginates (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medical University of South Carolina
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients With Successful Eradication |
45.5; 38.1; 36.4; 19.04 | — |
| SECONDARY Number of Treatments (Mean) |
3.1; 3.88; 3.75; 5 | — |
Summary
This study evaluates the addition of an alginate based solution to twice daily proton pump inhibitor therapy (PPI) in patients undergoing ablative therapy for dysplastic Barrett's esophagus. The investigators hypothesize that the addition of this medication will help to achieve complete remission of Barrett's over a shorter period of time.
Eligibility Criteria
Inclusion Criteria
- (1) Age 18 (2) Biopsy-proven complicated BE (low/high grade grade dysplasia or IMC, confirmed by our institution's GI pathologist) As part of standard of care, all patients' biopsies will be confirmed with the institutions' GI pathologist and, either with outside biopsies or from biopsies completed at the primary institution.
Exclusion Criteria
- 1) Moderate to severe renal impairment, as defined by eGFR< 60 for 2 consecutive readings (2) Lack of capacity for decision-making (3) Allergy to hydroxybenzoates (4) Patients with uncontrolled hypertension or decompensated heart failure (5) Pregnancy- patients of child-bearing potential will be tested. (6) Patients with elevated calcium or potassium on screening laboratory testing (labs completed within the last month)
Data sourced from ClinicalTrials.gov (NCT03193216). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.