Acute Pancreatitis
Conditions
Keywords
pancreatitis, MRI, APACHEⅡ, T2*, T2 star
Brief summary
To quantitatively analyze the T2\* values of the head, body, and tail of normal pancreas, and observe the value of GRE T2\*-weighted MRI in the diagnosis of acute pancreatitis and the relationship between the T2\* value and the severity of AP.
Detailed description
1. We design a prospective study about Magetic Resonance Imaging Study of Acute Pancreatitis. 2. We apply for an account and register our study on the clinicalTrials. 3. In patients with acute pancreatitis, imaging is recommended to confirm the clinical diagnosis, investigate the etiology, and grade the severity of the disease . MR had the excellent resolution of soft tissue，and it has earned an ever more important role in the diagnosis of AP. With the continuous development of MR scanning techniques, the sequence of a multi-echo gradient recalled echo (GRE) T2\*-weighted imaging (T2\*WI), which acquires a spin echo signal, T2\* relaxation acquires a gradient echo signal, is a relatively new MRI technique. The sequence of a GRE T2\*WI requires high uniformity of the magnetic field, plus it can provide the T2\* value, which can indirectly reflect changes in tissue biochemical components, thus it can be used for the early diagnosis quantitative diagnosis of some diseases . 4. This calculation process for T2\* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning. 5. AP is a process of inflammation diffusion, in which cell edema will lead to hydrogen proton increase. In the inflammatory exudation process, T2\* value will change. So we conduct our research. In this study, we will observe pancreas in the normal pancreas and AP, and discuss the relationship between T2\* value and that of AP graded by the MR severity index (MRSI) and Acute Physiology And Chronic Healthy Evaluation II (APACHE II) scores. 6. However, until now, there is no research on the sequence applied in the patients with AP.
Interventions
None listed
Sponsors
Affiliated Hospital of North Sichuan Medical College
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* acute onset of abdominal pain; * pancreatitis at first onset; * three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and * abdominal MR examination.
Exclusion criteria
* inability to cooperate when MR imaging was performed; * a history of chronic pancreatitis; * AP due to pancreatic carcinoma; * hypoproteinemia; * with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ; * with iron deposition disorder (e.g. diabetes or blood system diseases).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The T2* Values in the Diagnosis of AP | 1 year | Compare the difference of the T2\* value between the AP group and the control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Difference of T2* Value Between the Edematous AP and Necrotizing AP | 1 year | Compare the difference of the T2\* value between the edematous AP group and necrotizing AP group |
| The T2* Value in Different Severity of AP According to MRSI | 1 year | AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index . |
| The Relationship Between the T2* Value and the Severity of AP According to Apache II | 1 year | In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system. |
Countries
China
Participant flow
Recruitment details
Patients with AP admitted to our institution between August 2013 and March 2015 were recruited in this study.
Pre-assignment details
Patients with iron deposition disorder or chroic blood system diseases should be excluded in this study, because these diseases can lead to the change of the T2\* value.
Participants by arm
| Arm | Count |
|---|---|
| Acute Pancreatitis All AP patients underwent the MRI scan within three days after admission. All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position. | 117 |
| Controlgroup All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position. | 51 |
| Total | 168 |
Baseline characteristics
| Characteristic | Acute Pancreatitis | Controlgroup | Total |
|---|---|---|---|
| Age, Continuous | 50.41 years STANDARD_DEVIATION 15.55 | 50.90 years STANDARD_DEVIATION 17.83 | 50.56 years STANDARD_DEVIATION 16.22 |
| Region of Enrollment China | 117 participants | 51 participants | 168 participants |
| Sex: Female, Male Female | 45 Participants | 20 Participants | 65 Participants |
| Sex: Female, Male Male | 72 Participants | 31 Participants | 103 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 117 | 0 / 51 |
| serious Total, serious adverse events | 0 / 117 | 0 / 51 |
Outcome results
Primary
The T2* Values in the Diagnosis of AP
Compare the difference of the T2\* value between the AP group and the control group.
Time frame: 1 year
Population: compare T2\* value between the AP group and the control group using independent sample t test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Pancreatitis | The T2* Values in the Diagnosis of AP | 25.86 ms | Standard Deviation 4.9 |
| Control Group | The T2* Values in the Diagnosis of AP | 21.06 ms | Standard Deviation 2.64 |
Comparison: The independent T test was used to determine the differences for the T2\* value between the Control group and AP group.p-value: <0.01t-test, 2 sided
Secondary
The Difference of T2* Value Between the Edematous AP and Necrotizing AP
Compare the difference of the T2\* value between the edematous AP group and necrotizing AP group
Time frame: 1 year
Population: compare the difference of T2\* value between the edematous AP and necrotizing AP
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Pancreatitis | The Difference of T2* Value Between the Edematous AP and Necrotizing AP | 25.28 ms | Standard Deviation 4.56 |
| Control Group | The Difference of T2* Value Between the Edematous AP and Necrotizing AP | 28.10 ms | Standard Deviation 5.59 |
Comparison: The independent T test was used to determine the differences for the T2\* value between the edematous AP and necrotizing APp-value: 0.05t-test, 2 sided
Secondary
The Relationship Between the T2* Value and the Severity of AP According to Apache II
In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (≥8 points) according to the APACHE II scoring system.
Time frame: 1 year
Population: Indengpent T test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Pancreatitis | The Relationship Between the T2* Value and the Severity of AP According to Apache II | 25.73 ms | Standard Deviation 4.8 |
| Control Group | The Relationship Between the T2* Value and the Severity of AP According to Apache II | 26.25 ms | Standard Deviation 5.26 |
p-value: 0.629t-test, 2 sided
Secondary
The T2* Value in Different Severity of AP According to MRSI
AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .
Time frame: 1 year
Population: AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Acute Pancreatitis | The T2* Value in Different Severity of AP According to MRSI | 24.08 ms | Standard Deviation 4.41 |
| Control Group | The T2* Value in Different Severity of AP According to MRSI | 26.49 ms | Standard Deviation 4.91 |
| Severe AP | The T2* Value in Different Severity of AP According to MRSI | 29.99 ms | Standard Deviation 3.83 |
Comparison: Analysis of variance (ANOVA) was used to assess the differences in the T2\* value between the mild, moderate, and severe AP groups according to the MRSI score.p-value: <0.01ANOVA
Comparison: compare the T2\* value in the mild and moderate AP according to MRSIp-value: 0.0111t-test, 2 sided
Comparison: compare the T2\* value between the mild and severe APp-value: 0.002t-test, 2 sided
Comparison: compare the T2\* value between the moderate and severe AP according to MRSIp-value: 0.071t-test, 2 sided