Ursodeoxycholic Acid in Barrett's Endotherapy

NCT07756710 | Not Yet Recruiting

• 1 other identifier: ACYY0832
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Barrett's Esophagus With Dysplasia

Keywords

ursodeoxycholic acid; Barrett's Esophagus

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (1)

• Effects of UDCA on refluxate bile acid composition

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

Other Outcomes (1)

• Number of treatment sessions required to achieve complete eradication of BE

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

Study Arms (1)

Patients with Barrett's esophagus-associated neoplasia

Patients with Barrett's esophagus-associated neoplasia who are being treated with UDCA and are undergoing endoscopic eradication therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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).

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Columbia University: lead
• American Society for Gastrointestinal Endoscopy: collaborator

Study Sites (1)

Columbia University Irving Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Julian Abrams, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katharine Godfrey

CONTACT

6463170740; kb3217@cumc.columbia.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Study Record Dates

• First Submitted: August 7, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: August 11, 2026

Record last verified: 2026-08

Locations

US (1)