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出境医 / 临床实验 / Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis
Classification and Comparison of Early-onset and Late-onset Idiopathic Chronic Pancreatitis
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 |
|---|
| 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 : | January 1, 2000 |
| Estimated Primary Completion Date : | December 31, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Group/Cohort |
|---|
|
ICP cohort
Patients with idiopathic pancreatitis
|
Outcome Measures
Primary Outcome Measures :
- 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.
- 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 :
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
| 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
Contacts and Locations
Locations
| China | |
| Changhai Hospital, Second Military Medical University | |
| Shanghai, China, 200433 | |
Sponsors and Collaborators
Changhai Hospital
Investigators
| Principal Investigator: | Zhaoshen Li, Doctor | Changhai Hospital |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||
| First Posted Date | May 17, 2019 | ||||
| Last Update Posted Date | September 12, 2019 | ||||
| Actual Study Start Date | January 1, 2000 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
|
||||
| Original Primary Outcome Measures | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | 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 | ||||
| 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. | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Idiopathic chronic pancreatitis patients in China | ||||
| Condition |
|
||||
| Intervention | Not Provided | ||||
| Study Groups/Cohorts | ICP cohort
Patients with idiopathic pancreatitis
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status | Active, not recruiting | ||||
| Actual Enrollment |
1633 | ||||
| Original Actual Enrollment | Same as current | ||||
| Estimated Study Completion Date | December 31, 2019 | ||||
| Estimated Primary Completion Date | December 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
||||
| Sex/Gender |
|
||||
| Ages | Child, Adult, Older Adult | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | China | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03953937 | ||||
| Other Study ID Numbers | ICP-1 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
||||
| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Zhaoshen Li, Changhai Hospital | ||||
| Study Sponsor | Changhai Hospital | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
||||
| PRS Account | Changhai Hospital | ||||
| Verification Date | September 2019 | ||||
