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临床试验/NCT05450627
NCT05450627已完成不适用

Development of a Registry of Patients With Pancreatic Exocrine Insufficiency of Different Etiologies: EURO-PEI Registry

Hospital Clinico Universitario de Santiago2 个研究点 分布在 1 个国家目标入组 1,015 人开始时间: 2021年6月1日最近更新:
适应症
干预措施
相关药物

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

J. Enrique Domínguez-Muñoz

Head of the Department of Gastroenterology

Hospital Clinico Universitario de Santiago

研究点 (2)

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