Chronic Pancreatitis, Genetic Mutation, Smoking, Tobacco, Drinking, Alcohol
Conditions
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.
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.
Interventions
BEHAVIORALsmoking and alcohol assumption
documenting the change of smoking and drinking status during the follow-up period
DIAGNOSTIC_TESTgenetic sequencing
sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.
Sponsors
Changhai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Death | 20 years | all-cause death |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| G+/E+ Group 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+). | 180 |
| G-/E+ Group 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+). | 263 |
| G+/E- Group 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+). | 230 |
| G-/E- Group 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+). | 125 |
| Total | 798 |
Baseline characteristics
| Characteristic | G+/E+ Group | Total | G-/E- Group | G+/E- Group | G-/E+ Group |
|---|---|---|---|---|---|
| Age, Continuous | 37.5 years | 35.5 years | 36.0 years | 17.5 years | 44.0 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 180 Participants | 798 Participants | 125 Participants | 230 Participants | 263 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment China | 180 Participants | 798 Participants | 125 Participants | 230 Participants | 263 Participants |
| Sex: Female, Male Female | 7 Participants | 239 Participants | 81 Participants | 147 Participants | 4 Participants |
| Sex: Female, Male Male | 173 Participants | 559 Participants | 44 Participants | 83 Participants | 259 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 6 / 180 | 9 / 263 | 4 / 230 | 5 / 125 |
| other Total, other adverse events | 0 / 180 | 0 / 263 | 0 / 230 | 0 / 125 |
| serious Total, serious adverse events | 0 / 180 | 0 / 263 | 0 / 230 | 0 / 125 |
Outcome results
Primary
the Number of Patients Developing Pancreatic Insufficiency
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| G+/E+ Group | the Number of Patients Developing Pancreatic Insufficiency | 82 Participants |
| G-/E+ Group | the Number of Patients Developing Pancreatic Insufficiency | 130 Participants |
| G+/E- Group | the Number of Patients Developing Pancreatic Insufficiency | 55 Participants |
| G-/E- Group | the Number of Patients Developing Pancreatic Insufficiency | 36 Participants |
Secondary
Death
all-cause death
Time frame: 20 years