Ursodeoxycholic Acid in Barrett's Endotherapy

Official record

Identifier

NCT07756710

Recruiting locations

country

United States

Interventions studied

Not provided in the official record

Lead sponsor

Columbia University

Target enrolment

15 participants

Study type

OBSERVATIONAL

Phase

Not provided in the official record

Status

Not yet recruiting

First posted

Aug 11, 2026

Last updated on the registry

Aug 11, 2026

Age

18 Years

Sex

ALL

Study contact

The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.

Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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).

Indexed under

Esophageal Cancer