Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03953937
• Other study ID #: ICP-1
• Status: Active, not recruiting
• Start date: January 1, 2000
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2019
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Classification of early-onset idiopathic chronic pancreatitis (EOICP) and late-onset idiopathic chronic pancreatitis (LOICP) was proposed based on bimodal distribution of age at onset of idiopathic chronic pancreatitis (ICP). However, studies of larger populations prove it may be normal distribution. Therefore, the aim of the study is to find what the distribution of age at onset of ICP is and whether the classification of EOICP and LOICP is meaningful.

Description:

Idiopathic chronic pancreatitis (ICP) patients admitted to the investigator's center from January 2000 to December 2013 were enrolled. Characteristics were compared between early-onset idiopathic chronic pancreatitis (EOICP) and late-onset idiopathic chronic pancreatitis (LOICP) patients. Cumulative rates of diabetes mellitus, steatorrhea, pancreatic stone, pancreatic pseudocyst (PPC), biliary stricture, and pancreatic cancer after the onset and the diagnosis of ICP were calculated, respectively. Different cut-off values for age at onset of ICP were set to classify EOICP and LOICP. Then differences of clinical courses between EOICP and LOICP were compared when classified by distinct cut-off values.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1633
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with idiopathic 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

• Chronic pancreatic patients with identified etiologies

Related Conditions & MeSH terms

• Chronic Pancreatitis
• Idiopathic Chronic Pancreatitis
• Pancreatitis
• Pancreatitis, Chronic

Locations

Country	Name	City	State
China	Changhai Hospital, Second Military Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distribution of age at onset of idiopathic chronic pancreatitis	Identify the distribution of age at onset of idiopathic chronic pancreatitis.	December 31, 2013
Primary	Basic characteristics of early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis	Identify respective ratio of patients with male gender and patients with smoking history in early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis in traditional classification (traditional classification: age at onset of idiopathic chronic pancreatitis<35 years old as early-onset idiopathic chronic pancreatitis; age at onset of idiopathic chronic pancreatitis>35 years old as late-onset idiopathic chronic pancreatitis).	December 31, 2013
Secondary	Basic characteristics of early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis with different cut-off values for age at onset of idiopathic chronic pancreatitis	Identify respective ratio of patients with male gender and patients with smoking history in early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019
Secondary	Diabetes mellitus	Evaluate incidence and cumulative incidence of endocrine insufficiency developed in early-onset and late-onset idiopathic chronic pancreatitis patients with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019
Secondary	Steatorrhea	Evaluate incidence and cumulative incidence of exocrine insufficiency developed in early-onset and late-onset idiopathic chronic pancreatitis patients with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019
Secondary	Pancreatic pseudocyst	Evaluate incidence and cumulative incidence of pancreatic pseudocyst developed in early-onset and late-onset idiopathic chronic pancreatitis patients with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019
Secondary	Common bile duct stricture	Evaluate incidence and cumulative incidence of common bile duct stricture developed in early-onset and late-onset idiopathic chronic pancreatitis patients with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019
Secondary	Pancreatic cancer	Evaluate incidence and cumulative incidence of pancreatic cancer developed in early-onset and late-onset idiopathic chronic pancreatitis patients with different cut-off values for age at onset of idiopathic chronic pancreatitis.	August 31, 2019