Cohort Study of Patients With Barrett's Esophagus-Associated Neoplasia Receiving Ursodeoxycholic Acid in the Setting of Endoscopic Ablation
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Percent Neosquamous Regrowth (PNR) after a single treatment session
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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).
研究组 & 干预措施
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
结局指标
主要结局
Percent Neosquamous Regrowth (PNR) after a single treatment session
时间窗: 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.
次要结局
- Effects of UDCA on refluxate bile acid composition(Baseline endoscopy until complete eradication of BE or after 4 treatments (approximately 8-10 months))
研究者
Julian A Abrams, MD
Professor of Medicine and Epidemiology
Columbia University