An Observational Study on the Natural Course of Chronic Pancreatitis

Active, not recruiting

• Conditions: Smoking, Tobacco; Genetic Mutation; Drinking, Alcohol; Chronic Pancreatitis

• Registration Number: NCT04574297
• Lead Sponsor: Changhai Hospital

Brief Summary

To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.

Detailed Description

The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2020-05-31
• Study First Submitted: 2020-09-27
• Study First Submitted QC: 2020-09-30
• Study First Posted: 2020-10-05
• Results First Submitted: 2021-09-01
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-25
• Last Update Submitted: 2021-10-25
• Results First Posted: 2021-11-30
• Last Update Posted: 2021-11-30
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 798

Inclusion Criteria

• patients with a diagnosis of chronic pancreatitis
• agree to join the study and provide informed consent

Exclusion Criteria

• autoimmune pancreatitis
• pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
• the follow-up time less than 2 years
• patients presenting with diabetes and/or steatorrhea at onset of CP.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Number of Patients Developing Pancreatic Insufficiency	10 years	The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.

Secondary Outcome Measures

Name	Time	Method
Death	20 years	all-cause death