Registro Italiano Pancreatite Cronica
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Disease Progression
研究概览
简要总结
ITARECIPE is a multicenter national registry designed to study the diagnosis and evolution of Chronic Pancreatitis
详细描述
Chronic pancreatitis (PC) is a relatively rare disease (45/100,000 population) in Italy, with heterogeneous aetiology, clinical history and treatment.
Patients need to be treated by different specialists, but almost always the gastroenterologist is central in diagnosis and treatment.
The study will be the first National Registry, prospective and will collect data on the history of the disease and its outcomes.
Data will be collected through an electronic data collection form (e-CRF) that the Sponsor (AISP) will make available to the Participating Centres.
Patients enrolled will be both new diagnoses or follow-up visits of patients with a diagnosis already made no more than 1 year before the signing of informed consent for the study in question: only data on the diagnosis and follow-up visits prior to the signing of the informed consent will be collected retrospectively (no more than one year).
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 12 years;
- •Diagnosis "definite" or "probable" according to the "M-ANNHEIM" criteria;
- •First evidence of diagnosis within 12 months of enrolment.
排除标准
- •Age < 12 years;
- •History of known disease with certainty for > 12 months.
结局指标
主要结局
Disease Progression
时间窗: 5 years
The collection of data on disease progression in terms of the need for medical, endoscopic or surgical therapy, the risk of pancreatic exo-endocrine failure and the risk of developing pancreatic and extrapancreatic complications and death.
次要结局
未报告次要终点