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临床试验/NCT03324698
NCT03324698进行中(未招募)不适用

The Natural History of Chronic Pancreatitis: A Multicenter Study

Changhai Hospital1 个研究点 分布在 1 个国家目标入组 4,000 人开始时间: 2000年1月1日最近更新:
适应症

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

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

Zhaoshen Li

Director of Gastroenterology Dept.

Changhai Hospital

研究点 (1)

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