This phase I trial evaluates whether ursodeoxycholic acid (UDCA) improves the effectiveness of ablation treatment for Barrett's esophagus (BE). Research has shown an association between reflux events and response to ablation therapy. Specifically, patients with increased exposure to reflux bile acids are less likely to respond to ablation treatments. UDCA is a drug commonly used to dissolve or prevent cholesterol gallstones by blocking hepatic cholesterol production and decreasing bile cholesterol. It may reduce acids in refluxate. By reducing exposure of the esophagus to acids in refluxate, UDCA may promote the regrowth of healthy tissue after ablation, thereby improving response to ablation treatment in patients with BE.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07756710.
Locations matching your search criteria
United States
New York
New York
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer CenterStatus: Active
Contact: Julian Abrams
Phone: 212-342-0476
PRIMARY OBJECTIVE:
I. To assess the extent of neosquamous regrowth after a single ablation in BE patients who are being treated with ursodiol (UDCA) and are undergoing ablation.
SECONDARY OBJECTIVES:
I. Participation rate.
II. Compliance with study medication.
III. Adverse event rates.
IV. Within-individual changes in total deoxycholic acid (DCA) concentrations.
OUTLINE:
Patients receive UDCA orally (PO) twice daily (BID) beginning at least 2 weeks prior to their initial endoscopic ablation treatment and continuing until eradication of BE or after 4 ablation treatments, whichever occurs first. Patients undergo endoscopy followed by endoscopic ablation at baseline and then every 2 months until complete eradication of BE is achieved. Patients also undergo collection of gastric aspirate samples on study.
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorJulian Abrams
