Clinical trial NCT03953937: Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis
Official title: Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Pancreatitis
Idiopathic Chronic Pancreatitis
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2019-05-17
Enrollment: 1633
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Idiopathic chronic pancreatitis patients in China

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.

Eligibility criteria: 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

Primary outcomes:
measure: Distribution of age at onset of idiopathic chronic pancreatitis
timeFrame: December 31, 2013
measure: Basic characteristics of early-onset idiopathic chronic pancreatitis and late-onset idiopathic chronic pancreatitis
timeFrame: December 31, 2013
Secondary outcomes:
measure: 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
timeFrame: August 31, 2019
measure: Diabetes mellitus
timeFrame: August 31, 2019
measure: Steatorrhea
timeFrame: August 31, 2019
measure: Pancreatic pseudocyst
timeFrame: August 31, 2019
measure: Common bile duct stricture
timeFrame: August 31, 2019
measure: Pancreatic cancer
timeFrame: August 31, 2019
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Second Military Medical University
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, Doctor
role: PRINCIPAL_INVESTIGATOR
References: