Assessment of Esophageal Distensibility and Mucosal Impedance in Dysplastic Barrett's Esophagus Patients Undergoing Radiofrequency Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Changes in distensibility index (DI)
研究概览
简要总结
Patients undergoing ablative therapy for management of dysplastic Barrett's Esophagus (BE) will have decreased distensibility over the course of treatment, but improvement in mucosal impedance as BE epithelia is replaced by neosquamous epithelia. This information may lead to further research in predicting therapeutic response and complications. The purpose of this research is to collect information while measuring changes related to the esophagus in patients that receive radiofrequency ablation (RFA) for dysplastic Barrett's Esophagus (BE) or esophageal cancer. Study participation includes measurements of the esophagus with the use of two different devices. This takes place during clinically indicated upper endoscopies during the timeframe the participant is receiving RFA treatments. This process will take up to an additional 10 minutes during the upper endoscopy and be done while the participant is sedated.
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
- •Male or female ≥ 18 years of age
- •Confirmed histologic diagnosis of BE with dysplasia or intramucosal carcinoma (IMCa)
- •Ability to take high-dose proton pump inhibitor (PPI) therapy (such as omeprazole 40 mg BID)
- •Willing to undergo multiple rounds of endoscopic eradication therapy (EET) for management of BE (which is the guideline clinical recommendation for management of this disease)
排除标准
- •History of esophageal ablation
- •History of esophageal stricture
- •History of esophageal or gastric surgery
- •Pregnancy
- •History of esophageal cancer treated with radiation or chemotherapy
- •History of achalasia
- •History of delayed gastric emptying confirmed by 4-hour gastric emptying study
- •Received injection of glucagon like peptide 1 agonists within a few days prior to EGD
- •Adults lacking the capacity to consent for self
结局指标
主要结局
Changes in distensibility index (DI)
时间窗: Every 12 weeks, up to 1 year (4 visits)
Change in DI will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
Changes in diameter
时间窗: Every 12 weeks, up to 1 year (4 visits)
Change in esophageal diameter will be measured by functional luminal impedance planimetry (FLIP) during RFA procedure.
次要结局
- Changes in mucosal impedance(Every 12 weeks, up to 1 year (4 visits))