Ursodeoxycholic Acid in Barrett's Endotherapy

ConditionBarrett's Esophagus With Dysplasia

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorColumbia University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Allergy, hypersensitivity, or intolerance to UDCA.

Age ≤18 years.

Pregnant or planning to get pregnant during the study period.

Unable to give informed consent.

Trial population

Patients with Barrett's esophagus (BE) and low-grade dysplasia (LGD), high-grade dysplasia (HGD), or intramucosal adenocarcinoma undergoing endoscopic eradication therapy who are taking ursodeoxycholic acid (UDCA).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

15 Participants

are grouped into 1 trial group

Group A: Patients with Barrett's esophagus-associated neoplasia

Trial 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)

Other outcomes

Number of treatment sessions required to achieve complete eradication of BE

Investigators will calculate the proportion of patients requiring ≤3 ablation treatments to achieve complete eradication of Barrett's Esophagus (CE-BE). Median and IQR will be calculated for the number of treatment sessions required to achieve CE-BE.

Time frame

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

Sponsors and contacts

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Columbia University

Lead sponsor

American Society for Gastrointestinal Endoscopy

Collaborator

Source ClinicalTrials.gov

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