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

September 11, 2019 updated by: Zhaoshen Li, Changhai Hospital
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1633

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Idiopathic chronic pancreatitis patients in China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ICP cohort
Patients with idiopathic pancreatitis

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
December 31, 2013
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).
December 31, 2013

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
August 31, 2019
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.
August 31, 2019
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.
August 31, 2019
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.
August 31, 2019
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.
August 31, 2019
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.
August 31, 2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2000

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 8, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 12, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 11, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ICP-1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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