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NCT Number: NCT07756710

Ursodeoxycholic Acid in Barrett's Endotherapy

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.

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Key information

Conditions

Barrett's Esophagus With Dysplasia Barrett Esophagus Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Neoplasms Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Columbia University Irving Medical Center

New York, 10032, United States

Location contact

Julian Abrams, MD

PRINCIPAL_INVESTIGATOR

Katharine Godfrey

CONTACT

[email protected]

6463170740

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Percent Neosquamous Regrowth (PNR) after a single treatment session

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

    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.

Secondary outcomes

  1. Effects of UDCA on refluxate bile acid composition

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

    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).

Other outcomes

  1. Number of treatment sessions required to achieve complete eradication of BE

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Katharine Godfrey

CONTACT

[email protected]

6463170740

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • American Society for Gastrointestinal Endoscopy

Registry information

Official study title

Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 11, 2026
Registry last updated
Aug 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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