Trial Outcomes & Findings for Magnetic Resonance Imaging Study of Acute Pancreatitis (NCT NCT01911689)

Results Overview

Compare the difference of the T2\* value between the AP group and the control group.

Recruitment status

COMPLETED

Target enrollment

168 participants

Primary outcome timeframe

1 year

Results posted on

2015-08-24

Participant Flow

Patients with AP admitted to our institution between August 2013 and March 2015 were recruited in this study.

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.

Participant milestones

Participant milestones
Measure	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).
Overall Study STARTED	117	51
Overall Study COMPLETED	117	51
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Magnetic Resonance Imaging Study of Acute Pancreatitis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Acute Pancreatitis n=117 Participants 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.	Controlgroup n=51 Participants All MRI examinations were performed with a 3.0T scanner (Discovery MR 750; GE Medical Systems, Milwaukee, Wis) in the supine position.	Total n=168 Participants Total of all reporting groups
Age, Continuous	50.41 years STANDARD_DEVIATION 15.55 • n=5 Participants	50.90 years STANDARD_DEVIATION 17.83 • n=7 Participants	50.56 years STANDARD_DEVIATION 16.22 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	20 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	72 Participants n=5 Participants	31 Participants n=7 Participants	103 Participants n=5 Participants
Region of Enrollment China	117 participants n=5 Participants	51 participants n=7 Participants	168 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: compare T2\* value between the AP group and the control group using independent sample t test

Compare the difference of the T2\* value between the AP group and the control group.

Outcome measures

Outcome measures
Measure	Acute Pancreatitis n=117 Participants T2\* value of AP group is mean T2\* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP 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	Control Group n=51 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	Severe AP Severe AP was defined as 7-10 points according to MRSI.
The T2* Values in the Diagnosis of AP	25.86 ms Standard Deviation 4.90	21.06 ms Standard Deviation 2.64	—

SECONDARY outcome

Timeframe: 1 year

Population: compare 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

Outcome measures

Outcome measures
Measure	Acute Pancreatitis n=93 Participants T2\* value of AP group is mean T2\* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP 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	Control Group n=24 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	Severe AP Severe AP was defined as 7-10 points according to MRSI.
The Difference of T2* Value Between the Edematous AP and Necrotizing AP	25.28 ms Standard Deviation 4.56	28.10 ms Standard Deviation 5.59	—

SECONDARY outcome

Timeframe: 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 .

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 .

Outcome measures

Outcome measures
Measure	Acute Pancreatitis n=41 Participants T2\* value of AP group is mean T2\* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP 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	Control Group n=69 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	Severe AP n=7 Participants Severe AP was defined as 7-10 points according to MRSI.
The T2* Value in Different Severity of AP According to MRSI	24.08 ms Standard Deviation 4.41	26.49 ms Standard Deviation 4.91	29.99 ms Standard Deviation 3.83

SECONDARY outcome

Timeframe: 1 year

Population: Indengpent T test

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.

Outcome measures

Outcome measures
Measure	Acute Pancreatitis n=89 Participants T2\* value of AP group is mean T2\* values of the head, body and tail of pancreas respectively (If AP with necrosis, measureing the corresponding to the area with no necrosis).The AP 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	Control Group n=28 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	Severe AP Severe AP was defined as 7-10 points according to MRSI.
The Relationship Between the T2* Value and the Severity of AP According to Apache II	25.73 ms Standard Deviation 4.80	26.25 ms Standard Deviation 5.26	—

Adverse Events

Acute Pancreatitis

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Controlgroup

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.XiaoMing Zhang

Sichuan Key Laboratory of Medical Imaging, Department of Radiology, Affiliated Hospital of North Sichuan Medical College

Phone: +86 817 2262218

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place