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Ursodeoxycholic acid during Barrett's esophagus treatment with endoscopic ablation

Follows people with Barrett's esophagus taking ursodeoxycholic acid during endoscopic treatment.

Key facts

Who runs it
Columbia University
Where
New York, United StatesSee the site
Trial code
Registry title
Ursodeoxycholic Acid in Barrett's Endotherapy
Status
Not yet recruiting
People taking part
15 people, planned
Started
Nov 2026
Expected to end
Nov 2027
Type of study
Observational
Record updated
11 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Barrett's esophagus with dysplasia or early cancer. They are taking UDCA and having endoscopic treatment to remove the abnormal tissue.

Age
Older than 18 years.
Sex
All sexes can join.
Disease stage
Barrett's esophagus confirmed by endoscopy and biopsy showing intestinal metaplasia. Before treatment, tissue must show low- or high-grade dysplasia or intramucosal adenocarcinoma. Barrett's length must be ≥2 cm (0.8 in) (Prague classification: any C, M≥2).
Earlier treatment
Must be taking UDCA 13-15 mg/kg split into two doses a day. Either no earlier endoscopic ablation, or one earlier ablation with <50% response and ≥2 cm (0.8 in) of Barrett's left. Earlier endoscopic removal of focal lesions is allowed. Nodular lesions must be removed before ablation starts.

Main reasons for not taking part

  • Allergy, hypersensitivity or intolerance to UDCA.
  • Age 18 years or younger.
  • Pregnant or planning to get pregnant during the study.
  • Unable to give informed consent.
  • Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis or biliary-gastrointestinal fistula.

The registry criteria, word for word

Show all 11 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Allergy, hypersensitivity, or intolerance to UDCA
  • Known acute cholecystitis, cholangitis, biliary obstruction, gallstone pancreatitis, or biliary-gastrointestinal fistula (contraindications to UDCA use)
  • Age ≤18 years
  • Pregnant or planning to get pregnant during the study period
  • Unable to give informed consent

Where in United States

  • Columbia University Irving Medical CenterNew York, United StatesContact: Katharine GodfreyNot yet recruiting

About the trial

What the trial wants to find out

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.

The group in the trial

  • 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

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation
Plain-language title
Ursodeoxycholic acid during Barrett's esophagus treatment with endoscopic ablationGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Record updated
11 August 2026