Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies: EURO-PEI Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,015
- 试验地点
- 2
- 主要终点
- Dose of oral pancreatic enzymes
研究概览
简要总结
EURO-PEI is a multicentre, observational registry conducted at eight specialist pancreatic centres in Spain, Hungary, France, Italy, and the United Kingdom. The registry was designed to capture routine specialist practice without protocol-mandated diagnostic testing, PERT dosing, proton pump inhibitor (PPI) use, or follow-up intervals. Adults aged 18 years or older are eligible if they have a clinician-established diagnosis of PEI and PERT is initiated or actively managed during specialist follow-up. Patients already receiving PERT at registry inclusion, including those entered from any pre-existing database, are eligible if the diagnosis of PEI and the indication for ongoing treatment are confirmed by the treating specialist. Patients may have acute pancreatitis, chronic pancreatitis, cystic fibrosis, pancreatic cancer, pancreatectomy, or other pancreatic or extrapancreatic conditions potentially leading to PEI.
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
- •Patients older than 18 years diagnosed with PEI secondary to pancreatic diseases, pancreatectomy, or gastrectomy.
- •Willingness to participate in the study.
排除标准
- •Patients with pancreatic diseases without PEI.
- •Pregnancy
- •Known allergy to oral pancreatic enzymes
- •Any condition avoiding adequate clinical management of PEI.
- •Patients who are not willing to participate in the study.
研究组 & 干预措施
Patients with PEI secondary to different etiologies
Adult patients diagnosed with pancreatic exocrine insufficiency secondary to chronic pancreatitis, pancreatic cancer, pancreatectomy, acute pancreatitis, and other stiologies.
干预措施: Pancreatic Enzyme (Drug)
结局指标
主要结局
Dose of oral pancreatic enzymes
时间窗: Six months
Dose required for symptoms relief and normalization of the nutritional status
次要结局
未报告次要终点
研究者
J. Enrique Domínguez-Muñoz
Head of the Department of Gastroenterology
Hospital Clinico Universitario de Santiago
