Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03953937
Recruitment Status : Active, not recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

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
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.

Layout table for study information
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 : January 1, 2000
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort
ICP cohort
Patients with idiopathic pancreatitis



Primary Outcome Measures :
  1. Distribution of age at onset of idiopathic chronic pancreatitis [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Idiopathic chronic pancreatitis patients in China
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953937


Locations
Layout table for location information
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhaoshen Li, Doctor Changhai Hospital

Layout table for additonal information
Responsible Party: Zhaoshen Li, Director of Gastroenterology Department, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03953937     History of Changes
Other Study ID Numbers: ICP-1
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases