An Observational Study on the Natural Course of Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

The Impact of Genetic and Environmental Factors on the Progression of Chronic Pancreatitis：An Observational Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04574297
• Other study ID #: CP-2011
• Status: Active, not recruiting
• Start date: January 1, 2011
• Est. completion date: December 31, 2030

Study information

• Verified date: October 2021
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 798
• Est. completion date: December 31, 2030
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Chronic Pancreatitis
• Drinking, Alcohol
• Genetic Mutation
• Pancreatitis
• Pancreatitis, Chronic
• Smoking, Tobacco

Intervention

Behavioral:
• smoking and alcohol assumption
documenting the change of smoking and drinking status during the follow-up period

Diagnostic Test:
• genetic sequencing
sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Number of Patients Developing Pancreatic Insufficiency	The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.	10 years
Secondary	Death	all-cause death	20 years