An Observational Study on the Natural Course of Chronic Pancreatitis
Study Details
Study Description
Brief Summary
To explore the impact on genetic and environmental factors for clinical manifestation, and the progression of chronic pancreatitis, including development of pancreatic insufficiency and other complications.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Detailed Description
The present study was an observational study aimed to explore the impact of genetic factors (rare pathogenic variants of CP) and environmental factors(smoking and alcohol assumption) on the clinical manifestation and progression of CP. The observation items included the pain patterns, incidence of complications of CP, pancreatic cancer and death.
Study Design
Outcome Measures
Primary Outcome Measures
- the Number of Patients Developing Pancreatic Insufficiency [10 years]
The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only.
Secondary Outcome Measures
- Death [20 years]
all-cause death
Eligibility Criteria
Criteria
Inclusion Criteria:
-
patients with a diagnosis of chronic pancreatitis
-
agree to join the study and provide informed consent
Exclusion Criteria:
-
autoimmune pancreatitis
-
pancreatic cancer diagnosed within 2 years after the diagnosis of chronic pancreatitis
-
the follow-up time less than 2 years
-
patients presenting with diabetes and/or steatorrhea at onset of CP.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Changhai Hospital
Investigators
None specified.Study Documents (Full-Text)
More Information
Publications
None provided.- CP-2011
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group |
---|---|---|---|---|
Arm/Group Description | Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
Period Title: Overall Study | ||||
STARTED | 180 | 263 | 230 | 125 |
COMPLETED | 180 | 263 | 230 | 125 |
NOT COMPLETED | 0 | 0 | 0 | 0 |
Baseline Characteristics
Arm/Group Title | G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group | Total |
---|---|---|---|---|---|
Arm/Group Description | Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Total of all reporting groups |
Overall Participants | 180 | 263 | 230 | 125 | 798 |
Age (years) [Median (Inter-Quartile Range) ] | |||||
Median (Inter-Quartile Range) [years] |
37.5
|
44.0
|
17.5
|
36.0
|
35.5
|
Sex: Female, Male (Count of Participants) | |||||
Female |
7
3.9%
|
4
1.5%
|
147
63.9%
|
81
64.8%
|
239
29.9%
|
Male |
173
96.1%
|
259
98.5%
|
83
36.1%
|
44
35.2%
|
559
70.1%
|
Race (NIH/OMB) (Count of Participants) | |||||
American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Asian |
180
100%
|
263
100%
|
230
100%
|
125
100%
|
798
100%
|
Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
White |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Region of Enrollment (Count of Participants) | |||||
China |
180
100%
|
263
100%
|
230
100%
|
125
100%
|
798
100%
|
Outcome Measures
Title | the Number of Patients Developing Pancreatic Insufficiency |
---|---|
Description | The primary endpoint was the number of patients developing pancreatic insufficiency, categorised as 1) diabetes and steatorrhea, 2) diabetes only, or 3) steatorrhea only. |
Time Frame | 10 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title | G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group |
---|---|---|---|---|
Arm/Group Description | Genetic factor/s positive and environmental factor/s positive group. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative and environmental factor/s positive group.Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s positive group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | Genetic factor/s negative group and environmental factor/s negative. Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). |
Measure Participants | 180 | 263 | 230 | 125 |
Count of Participants [Participants] |
82
45.6%
|
130
49.4%
|
55
23.9%
|
36
28.8%
|
Title | Death |
---|---|
Description | all-cause death |
Time Frame | 20 years |
Outcome Measure Data
Analysis Population Description |
---|
[Not Specified] |
Arm/Group Title |
---|
Arm/Group Description |
Adverse Events
Time Frame | 10 years. | |||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | The definition of adverse event and/or serious adverse event is in accordance with the clinicaltrials.gov Definitions. | |||||||
Arm/Group Title | G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group | ||||
Arm/Group Description | genetic factor/s positive and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | genetic factor/s negative and environmental factor/s positive group Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | genetic factor/s positive group and environmental factor/s negative Patients with at least one rare pathogenic variant were considered genetic factor/s positive (denoted as G+). Patients with a history of either smoking or alcohol consumption were considered environmental factor/s positive (denoted as E+). | genetic factor/s negative group and environmental factor/s negative | ||||
All Cause Mortality |
||||||||
G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 6/180 (3.3%) | 9/263 (3.4%) | 4/230 (1.7%) | 5/125 (4%) | ||||
Serious Adverse Events |
||||||||
G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/180 (0%) | 0/263 (0%) | 0/230 (0%) | 0/125 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
G+/E+ Group | G-/E+ Group | G+/E- Group | G-/E- Group | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 0/180 (0%) | 0/263 (0%) | 0/230 (0%) | 0/125 (0%) |
Limitations/Caveats
More Information
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title | Dr. Zhuan Liao |
---|---|
Organization | Changhai Hospital |
Phone | 86-21-31161004 |
liaozhuan@smmu.edu.cn |
- CP-2011