The Natural History of Chronic Pancreatitis: A Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 4,000
- 试验地点
- 1
- 主要终点
- Pancreatic cancer
研究概览
简要总结
Chronic pancreatitis (CP) is a disease characterized by inflammation and their replacement by fibrotic tissue. The destruction of pancreatic function and structure are the main complications. This retrospective-prospective, multicenter, cohort study was conducted. This study aimed to observe the natural history of CP in China, analyse the risk factors for CP complications, and establish individual predictions.
详细描述
In order to track changes consistently throughout the course of CP and facilitate the evaluation and study of CP, a dedicated database, CP Database (version number 2.1, YINMA Information Technology Inc., Shanghai, China), was established to collect clinical data of CP patients who were admitted to our centers. Data befor CP Database established were retrospectively collected according to the electronic medical record system and complemented through telephone, letter, and e-mail inquiries. Data were prospectively collected since CP Database was established. The following information was documented in detail: demographic data (age, sex, birthplace, et al), course of CP, medical history, history of other diseases, smoking and alcohol history, family history of pancreatic diseases and diabetes mellitus (DM), laboratory and imaging findings, and treatment strategy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with chronic pancreatitis according to Asia-Pacific consensus
排除标准
- •Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
- •Groove pancreatitis
- •Autoimmune pancreatitis
结局指标
主要结局
Pancreatic cancer
时间窗: Dec 31, 2017
Pancreatic cancer developed in chronic pancreatitis patients
Steatorrhea
时间窗: Dec 31, 2017
Exocrine insufficiency developed in chronic pancreatitis patients
Diabetes mellitus
时间窗: Dec 31, 2017
Endocrine insufficiency developed in chronic pancreatitis patients
Common bile duct stricture
时间窗: Dec 31, 2017
Common bile duct stricture developed in chronic pancreatitis patients
Pancreatic pseudocyst
时间窗: Dec 31, 2017
Pancreatic pseudocyst developed in chronic pancreatitis patients
次要结局
未报告次要终点
研究者
Zhaoshen Li
Director of Gastroenterology Dept.
Changhai Hospital
