The Natural History of Chronic Pancreatitis

• Conditions: Complication; Risk Factors; Chronic Pancreatitis

• Registration Number: NCT03324698
• Lead Sponsor: Changhai Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-01-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-25
• Study First Submitted QC: 2017-10-27
• Last Update Submitted: 2017-10-27
• Study First Posted: 2017-10-30
• Last Update Posted: 2017-10-30
• Primary Completion: 2017-12-31
• Study Completion: 2018-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Patients diagnosed with chronic pancreatitis according to Asia-Pacific consensus

Exclusion Criteria

• Pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
• Groove pancreatitis
• Autoimmune pancreatitis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pancreatic cancer	Dec 31, 2017	Pancreatic cancer developed in chronic pancreatitis patients
Common bile duct stricture	Dec 31, 2017	Common bile duct stricture developed in chronic pancreatitis patients
Diabetes mellitus	Dec 31, 2017	Endocrine insufficiency developed in chronic pancreatitis patients
Steatorrhea	Dec 31, 2017	Exocrine insufficiency developed in chronic pancreatitis patients
Pancreatic pseudocyst	Dec 31, 2017	Pancreatic pseudocyst developed in chronic pancreatitis patients

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China