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

• Sponsor: Changhai Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03953937
• Collaborator: (none)
• Enrollment: 1,633
• Location: 1
• Anticipated Duration (Months): 240
• Patients Per Site Per Month: 6.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis; Idiopathic Chronic Pancreatitis

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 1633 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis
• Actual Study Start Date: Jan 1, 2000
• Anticipated Primary Completion Date: Dec 31, 2019
• Anticipated Study Completion Date: Dec 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
ICP cohort Patients with idiopathic pancreatitis

Outcome Measures

Primary Outcome Measures

1. Distribution of age at onset of idiopathic chronic pancreatitis [December 31, 2013]

   Identify the distribution of age at onset of idiopathic chronic pancreatitis.

2. 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 Outcome Measures

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Changhai Hospital, Second Military Medical University	Shanghai		China	200433

Sponsors and Collaborators

• Changhai Hospital

Investigators

• Principal Investigator: Zhaoshen Li, Doctor, Changhai Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Zhaoshen Li, Director of Gastroenterology Department, Changhai Hospital
• ClinicalTrials.gov Identifier: NCT03953937
• Other Study ID Numbers: ICP-1
• First Posted: May 17, 2019
• Last Update Posted: Sep 12, 2019
• Last Verified: Sep 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic

Study Results

No Results Posted as of Sep 12, 2019