Ursodeoxycholic Acid in Barrett's Endotherapy

N/ANot Yet RecruitingNCT07756710

Columbia University15 enrolled

Overview

Barrett's esophagus (BE) is a condition in which the normal lining of the esophagus is replaced by abnormal tissue that can increase the risk of esophageal cancer. Endoscopic eradication therapy (EET) removes this abnormal tissue, but most patients need several treatment sessions, leading to higher costs, inconvenience, and cumulative risk. Research suggests that bile reflux, especially a bile acid called deoxycholic acid (DCA), may interfere with healing after treatment by promoting regrowth of Barrett's tissue. Ursodeoxycholic acid (UDCA), an FDA-approved medication used for certain liver and gallbladder conditions, lowers harmful bile acids and may help the normal esophageal lining grow back more effectively. In this pilot study, patients undergoing endoscopic treatment and taking UDCA will be followed to see whether UDCA treatment improves healing and reduces the number of procedures needed. If successful, this approach could lower costs, decrease risks, and make treatment more accessible for patients at risk of esophageal cancer.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Barrett's Esophagus With Dysplasia

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Barrett's esophagus, defined as endoscopic evidence of BE with esophageal biopsies showing intestinal metaplasia. * Pre-treatment histology of low- or high-grade dysplasia or intramucosal adenocarcinoma. * BE length ≥2 cm (Prague classification: any C, M≥2). The decision was made to exclude patients with BE segments shorter than 2 cm, as assessment of % neosquamous regrowth in shorter segments is likely neither reliable nor highly reproducible. * Prior endoscopic resection of focal lesions is permitted. Endoscopic resection of nodular lesions must be performed prior to initiating ablation therapy. * Taking UDCA 13-15 mg/kg divided into twice daily dosing. * Either one of the following: * No prior endoscopic ablation therapy, OR * Single prior ablation treatment and \<50% response (i.e. \<50% neosquamous replacement of original BE segment) and ≥2 cm of residual BE Exclusion Criteria: * Allergy, hypersensitivity, or intolerance to UDCA. * Age ≤18 years. * Pregnant or planning to get pregnant during the study period. * Unable to give informed consent. * Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use).

Outcomes

Primary Outcomes

Percent Neosquamous Regrowth (PNR) after a single treatment session

At each endoscopy, photos will be taken starting at the GE junction and every 1 cm along the original length of BE. Three independent reviewers (the PI and two collaborators) will score the percent neosquamous regrowth based on the photo images comparing the baseline and follow-up endoscopy, with each reviewer blinded to the other reviewers' scores. PNR estimates will be made in increments of 5% (5%, 10%, 15%, etc.). The mean of the three reviewer's assessments will serve as the final PNR for each subject. We will then calculate the mean PNR with associated 95% CI for the study population.

Time frame: Baseline endoscopy to first follow-up endoscopy at approx. 2 months +/- 4 weeks

Secondary Outcomes

Effects of UDCA on refluxate bile acid composition

Within-individual change in total deoxycholic acids (DCAs) will be assessed and reported as median and interquartile range. Total DCAs will be calculated as the sum of the unconjugated and conjugated forms of DCA (DCA, glyco-DCA, tauro-DCA).

Time frame: Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months)