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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| acute pancreatitis | acute pancreatitis group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination. | ||
| controlgroup | normal control group:without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases). |
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| Measure | Description | Time Frame |
|---|---|---|
| The T2* Values in the Diagnosis of AP | Compare the difference of the T2* value between the AP group and the control group. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 year |
| The T2* Value in Different Severity of AP According to MRSI |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with AP admitted to our institution between August 2013 and March 2015 were considered for inclusion in this study. The inclusion criteria for patients in this study were as follows: (a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (d) abdominal MR examination.
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| Name | Affiliation | Role |
|---|---|---|
| zhang x ming, PHD | Affiliated Hospital of North Sichuan Medical College | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Hospital of North Sichuan Medical College | Nanchong | Sichuan | 637000 | China |
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.
Patients with AP admitted to our institution between August 2013 and March 2015 were recruited in this study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Acute Pancreatitis | acute pancreatitis group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination. |
| FG001 | Controlgroup | normal control group:without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Controlgroup |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The T2* Values in the Diagnosis of AP | Compare the difference of the T2* value between the AP group and the control group. | compare T2* value between the AP group and the control group using independent sample t test | Posted | Mean | Standard Deviation | ms | 1 year |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Acute Pancreatitis | Not Including Serious |
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Some diseases, such as chronic anemia, diabetes, etc., may lead to iron deposition in pancreas and may lead to change the T2* value.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.XiaoMing Zhang | Sichuan Key Laboratory of Medical Imaging, Department of Radiology, Affiliated Hospital of North Sichuan Medical College | +86 817 2262218 | cjr.zhxm@vip.163.com |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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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 .
| 1 year |
| 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. | 1 year |
All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
T2* value of control group is mean T2* values of the head, body and tail of pancreas respectively.The control group:without pancreatic disorders |
|
|
|
| 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 | compare the difference of T2* value between the edematous AP and necrotizing AP | Posted | Mean | Standard Deviation | ms | 1 year |
|
|
|
|
| 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 . | 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 . | Posted | Mean | Standard Deviation | ms | 1 year |
|
|
|
|
| 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. | Indengpent T test | Posted | Mean | Standard Deviation | ms | 1 year |
|
|
|
|
| 0 |
| 117 |
| 0 |
| 117 |
| EG001 | Controlgroup | Not Including Serious | 0 | 51 | 0 | 51 |
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| t-test, 2 sided |
| 0.0111 |
| 2-Sided |
| 95 |
| No |
| Superiority or Other |
| compare the T2* value between the mild and severe AP | t-test, 2 sided | 0.002 | 2-Sided | 95 | No | Superiority or Other |
| compare the T2* value between the moderate and severe AP according to MRSI | t-test, 2 sided | 0.071 | 2-Sided | 95 | No | Superiority or Other |