The DiNAM-EoE-C Study: Esophageal Distensibility and Novel Assessment of Motility in a Eosinophilic Esophagitis Cohort With Residual Symptoms Despite Histological Remission
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in esophageal distensibility plateau
研究概览
简要总结
Eosinophilic esophagitis is a chronic immune-mediated disease that may progress to fibrostenotic remodeling, leading to symptoms such as dysphagia, chest pain, and food impaction. Although current therapies aim to achieve inflammatory control and prevent fibrosis, some patients remain symptomatic despite endoscopic and histologic remission. In this subgroup, symptoms may reflect reduced esophageal distensibility, motility abnormalities, or altered symptom perception related to hypervigilance. This study aims to evaluate symptomatic EoE patients in histologic remission by assessing esophageal distensibility with FLIP before and after endoscopic dilation, investigating motility abnormalities with HRM, and exploring the role of hypervigilance in clinical outcomes.
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
- •Age ≥ 18 years;
- •Confirmed diagnosis of eosinophilic esophagitis in histological remission (<15 eosinophils/HPF);
- •Persistent symptoms (e.g., dysphagia, food impaction, chest pain) despite medical or dietary therapy;
- •Stable EoE therapy throughout the study duration (proton pump inhibitors, budesonide, dupilumab, dietary therapies);
- •Signed informed consent.
排除标准
- •Previous diagnosis of severe erosive esophagitis (Los Angeles grade C or higher);
- •Previous diagnosis of esophagogastric junction outflow disorders (e.g., achalasia);
- •Systemic diseases involving the esophagus (e.g., scleroderma);
- •Use or initiation during the study of immunosuppressive or biological drugs, or medications affecting esophageal motility (opioids, nitrates, calcium channel blockers);
- •Presence of R3 and/or S1 (according to EREFS).
研究组 & 干预措施
EoE Patients in Histologic Remission with persistent symptoms
EoE Patients in Histologic Remission with persistent symptoms without strictures underwent dilation and FLIP
结局指标
主要结局
Change in esophageal distensibility plateau
时间窗: 8-12 weeks
Change in esophageal distensibility plateau (mm) from baseline to 8-12 weeks post dilation
Change in esophageal body compliance
时间窗: 8-12 weeks
Change in esophageal body compliance (mm²/mmHg) from baseline to 8-12 weeks post dilation
Change in esophageal distensibility plateau, measured by functional lumen imaging probe (FLIP)
时间窗: 8-12 weeks
Change in esophageal distensibility plateau (mm) measured by functional lumen imaging probe (FLIP) from baseline to 8-12 weeks post dilation
Change in esophageal body compliance measured by functional lumen imaging probe (FLIP)
时间窗: 8-12 weeks
Change in esophageal body compliance (mm²/mmHg), measured by functional lumen imaging probe (FLIP) from baseline to 8-12 weeks post dilation
次要结局
- Clinical response to dilation(8-12 week post dilation)
研究者
Marina Coletta
Attending Doctor (MD, PhD)
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico