Ursodeoxycholic Acid in Barrett's Endotherapy

A vizsgálat adatai

Ki végzi

Columbia University

Azonosító

NCT07756710

A regiszteradat frissítve

2026. augusztus 11.

Eredeti leírás

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.A teljes eredeti leírásKevesebb

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

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.

Bevonási feltételek: 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.

Kizáró feltételek: 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.

ClinicalTrials.gov NCT07756710