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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03953937

Enrollment

1633

Registered

2019-05-17

Start date

2000-01-01

Completion date

2019-12-31

Last updated

2019-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pancreatitis, Idiopathic Chronic Pancreatitis

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Distribution of age at onset of idiopathic chronic pancreatitis	December 31, 2013	Identify the distribution of age at onset of idiopathic chronic pancreatitis.
Basic characteristics of early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis	December 31, 2013	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).

Secondary

Measure	Time frame	Description
Steatorrhea	August 31, 2019	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.
Pancreatic pseudocyst	August 31, 2019	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.
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	August 31, 2019	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.
Pancreatic cancer	August 31, 2019	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.
Common bile duct stricture	August 31, 2019	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.
Diabetes mellitus	August 31, 2019	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.

Countries

China

Outcome results