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Magnetic Resonance Imaging Study of Acute Pancreatitis

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ClinicalTrials.gov Identifier: NCT01911689
Recruitment Status : Completed
First Posted : July 30, 2013
Results First Posted : August 24, 2015
Last Update Posted : August 24, 2015
Sponsor:
Information provided by (Responsible Party):
Affiliated Hospital of North Sichuan Medical College

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.

Condition or disease
Acute Pancreatitis

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.

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Study Type : Observational
Actual Enrollment : 168 participants
Observational Model: Case Control
Time Perspective: Prospective
Study Start Date : August 2013
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Group/Cohort
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).



Primary Outcome Measures :
  1. The T2* Values in the Diagnosis of AP [ Time Frame: 1 year ]
    Compare the difference of the T2* value between the AP group and the control group.


Secondary Outcome Measures :
  1. The Difference of T2* Value Between the Edematous AP and Necrotizing AP [ Time Frame: 1 year ]
    Compare the difference of the T2* value between the edematous AP group and necrotizing AP group

  2. The T2* Value in Different Severity of AP According to MRSI [ Time Frame: 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 .

  3. The Relationship Between the T2* Value and the Severity of AP According to Apache II [ Time Frame: 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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
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.
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01911689


Locations
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China, Sichuan
Affiliated Hospital of North Sichuan Medical College
NanChong, Sichuan, China, 637000
Sponsors and Collaborators
Affiliated Hospital of North Sichuan Medical College
Investigators
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Study Chair: zhang x ming, PHD Affiliated Hospital of North Sichuan Medical College

Additional Information:

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Responsible Party: Affiliated Hospital of North Sichuan Medical College
ClinicalTrials.gov Identifier: NCT01911689     History of Changes
Other Study ID Numbers: SKLMC-2013-001
First Posted: July 30, 2013    Key Record Dates
Results First Posted: August 24, 2015
Last Update Posted: August 24, 2015
Last Verified: November 2014
Keywords provided by Affiliated Hospital of North Sichuan Medical College:
pancreatitis
MRI
APACHEⅡ
T2*
T2 star
Additional relevant MeSH terms:
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Pancreatitis
Pancreatic Diseases
Digestive System Diseases